meeting state of california environmental protection agency … › srp › trans_121317.pdf ·...
TRANSCRIPT
MEETING
STATE OF CALIFORNIA
ENVIRONMENTAL PROTECTION AGENCY
AIR RESOURCES BOARD
SCIENTIFIC REVIEW PANEL
ON TOXIC AIR CONTAMINANTS
CALIFORNIA ENVIRONMENTAL PROTECTION AGENCYSIERRA HEARING ROOM, 2ND FLOOR
1001 I STREETSACRAMENTO, CALIFORNIA
UNIVERSITY OF CALIFORNIA, LOS ANGELESFIELDING SCHOOL OF PUBLIC HEALTH, ROOM 73-320A
650 CHARLES E. YOUNG DRIVE, SOUTHLOS ANGELES, CALIFORNIA
WAIMEA PLANTATION COTTAGES9400 KAUMUALII HIGHWAY
WAIMEA, HAWAII
WEDNESDAY, DECEMBER 13, 2017
10:16 A.M.
JAMES F. PETERS, CSRCERTIFIED SHORTHAND REPORTERLICENSE NUMBER 10063
J&K COURT REPORTING, LLC 916.476.3171
A P P E A R A N C E S
PANEL MEMBERS:
Michael T. Kleinman, Ph.D., Chairperson
Cort Anastasio, Ph.D.
Jesús A. Araujo, M.D., Ph.D.
Paul D. Blanc, M.D.
Alan R. Buckpitt, Ph.D.
Stanton A. Glantz, Ph.D.
S. Katharine Hammond, Ph.D.(via teleconference)
Joseph R. Landolph, Jr., Ph.D.
Beate R. Ritz, M.D., Ph.D.(via teleconference)
REPRESENTING THE AIR RESOURCES BOARD:
Mr. Jim Behrmann, Panel Liaison
REPRESENTING THE OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT:
Dr. John Budroe, Chief, Air Toxicology Risk Assessment Section
Dr. John Faust, Chief, Air, Community and Environmental Research Branch
Dr. Lori Lim, Senior Toxicologist
Dr. David Siegel, Retired Annuitant
Dr. Rona Silva, Air, Community and Environmental Research Branch
J&K COURT REPORTING, LLC 916.476.3171
A P P E A R A N C E S C O N T I N U E D
REPRESENTING THE DEPARTMENT OF PESTICIDE REGULATION:
Dr. Terrell Barry, Exposure Assessor
Dr. Shelley DuTeaux, Chief, Human Health Assessment Branch
Dr. Svetlana Koshlukova, Senior Toxicologist, Risk Assessment Section
Mr. Randy Segawa, Special Advisor
Dr. Marylou Verder-Carlos, Assistant Director
J&K COURT REPORTING, LLC 916.476.3171
I N D E XPAGE
1. Continuation of the Panel’s review of “Tertiary-Butyl Acetate Inhalation Cancer Unit Risk Factor” - SRP Review Draft (November 2017) 4
In December 2016 the Office of Environmental Health Hazard Assessment (OEHHA) staff presented to the Panel a draft technical support document summarizing the carcinogenicity and derivation of an inhalation cancer unit risk for tertiary-butyl acetate (TBAc). In this meeting the Panel will discuss a revised technical support document (November 2017).
OEHHA is required to develop guidelines for conducting health risk assessments under the Air Toxics Hot Spots Program (Health) and Safety Code Section 44360(b)(2). The TBAc inhalation unit risk was developed using the most recent “Air Toxics Hot Spots Program Technical Support Document for Cancer Potency Factors” finalized by OEHHA in 2009. After the Panel’s review the document will be finalized and when adopted by the OEHHA Director the document will be included in Appendix B of the Air Toxics Hot Spots Program Technical Support Document for Cancer Potency Factors.
2. Overview of the draft report “Draft Evaluation of Chlorpyrifos as a Toxic Air Contaminant: Risk Characterization of Spray Drift, Dietary, and Aggregate Exposures to Residential Bystanders” (December 2017) 49
Department of Pesticide Regulation (DPR) staff will present an introductory briefing on the draft DPR report proposing to identify and list chlorpyrifos as a toxic air contaminant. The briefing is intended to provide background for the Panel’s review of the report which will continue at the Panel’s January 23, 2018 meeting. The draft DPR report will be posted in early December 2017 to the following DPR website under the Risk Assessment Documents tab:
J&K COURT REPORTING, LLC 916.476.3171
I N D E X C O N T I N U E D
3. Consideration of administrative matters. 122
The Panel may discuss various administrative matters and scheduling of future meetings.
Adjournment 127
Reporter's Certificate 128
J&K COURT REPORTING, LLC 916.476.3171
P R O C E E D I N G S
CHAIRPERSON KLEINMAN: Good morning, and welcome.
I'd like to call the meeting of the Scientific Review
Panel to order. And I want to welcome everybody to this
meeting of the Panel on Toxic Air Contaminants. We have
attendees here in Sacramento and we also have some people
listening and watching on a webcast.
And while I'm women welcoming everybody, I would
like to also extend a warm welcome to our returning Panel
Member Joe Landolph, who was appointed by the Assembly
Speaker earlier this year in the biochemistry and
molecular biology category on this Panel.
Joe has appointments in molecular microbiology
and immunology at the USC Keck School of medicine and in
the USC School of Pharmacy. He's also a member of the USC
Norris Comprehensive Cancer Center. And he served on this
panel quite a few years ago. You know, he had a long
tenure. And so I'm very happy to welcome Joe back.
I do want to remind those who are going to be
sneaking to use the microphones because we are webcasting.
And also, if you're using a laser pointer for slides, it
may not show up on the webcast, so speakers are going to
have to be a little more descriptive as they discuss their
PowerPoints.
Finally, if everybody can silence their phones or
J&K COURT REPORTING, LLC 916.476.3171
1
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
communications devices, that would be great.
And so now I'd like to first go around the table
and have the participants from the Panel just give a very
brief introduction, and then we'll also poll the members
who are calling in. So we can start with Dr. Landolph.
PANEL MEMBER LANDOLPH: It's a pleasure to com
back again. I certainly served with Stan Glantz and Paul
Blanc before. It's a pleasure to see all the new members.
And I know John Budroe. My research deals with nickel,
chromium, and arsenic carcinogenesis. We do a lot of work
in cell culture, may transform cell lines, and study the
activation oncogenes, knockout of tumor suppressor genes,
and the changes in global gene expression that this causes
leading to the transformed cell.
And I also teach microbiology and toxicology at
USC and I work in cancer, as Mike has pointed out. My
primary appointment point is in molecular microbiology and
immunology. And then the USC Norris Comprehensive Cancer
Center. And I serve on this Panel and also on the
Carcinogen Identification Committee Panel of the State of
California. Pleasure to be back.
PANEL MEMBER ANASTASIO: I'm Cort Anastasio. I'm
a Professor in the Department of Land, Air, and Water
Resources at UC Davis, and I study atmospheric chemistry.
PANEL MEMBER ARAUJO: I'm Jesús. Araujo I'm a
J&K COURT REPORTING, LLC 916.476.3171
2
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
Associate Professor or Medicine in the -- at the UCLA
School of Medicine, Environmental Health Sciences in the
School of Public Health. And I work on the cardiovascular
effects of ambient particular matter, as well as in
electronic cigarettes.
PANEL MEMBER BUCKPITT: I'm Alan Buckpitt from
the Department of Molecular Biosciences in the School of
Veterinary Medicine, and I'm retired.
PANEL MEMBER GLANTZ: I'm Stan Glantz. I'm a
Professor of Medicine at UC San Francisco. And I'm here
in the biostatistics seat.
PANEL MEMBER BLANC: And I'm Paul Blanc from the
University of California, San Francisco. I'm Chief of the
Division of Occupational and Environmental Medicine there.
And my background is in internal medicine, occupational
medicine and medical toxicology.
CHAIRPERSON KLEINMAN: Thank you. We are
supposed to have two participants on the phone. Kathy,
are you there?
Not hearing Kathy.
Beate, are you there?
CHAIRPERSON KLEINMAN: Well, I'll assume that
they will announce themselves when they are able to get on
line.
As it stands, we do have a quorum for this
J&K COURT REPORTING, LLC 916.476.3171
3
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
meeting. And so we can proceed to our next item of
business. So I'd like to again welcome all the panel
members and the people who are here to listen in on the
proceedings.
And we have two agenda items for today's meeting.
The first item is going to be the panel's second review of
the Inhalation Cancer Unit Risk Factor, or IUR, for the
tertiary-butyl acetate, also known as TBAc.
The IUR was developed using risk assessment
methodologies for developing IURs under the Air Toxics Hot
Spots Program. The document underwent public review and
comment in 2016. OEHHA presented the initial document to
the panel in December of 2016 for comment, at which time a
large number of recommendations were made and the document
has since been accordingly revised and changed. And that
document -- the revised Document will be presented today.
An additional written public comment by Lyondell
was also made to the SRP in March of 2017. And the
response to that public document will also be discussed.
So the lead Panel members for the document were
Dr. Araujo and myself. But many of the other Panel
members had comments, and so we'll start out with Dr.
Araujo and we'll also hear -- but before we do that, we'll
hear a presentation from the staff on the TBAc document as
it stands now. Then we'll use the time to discuss and
J&K COURT REPORTING, LLC 916.476.3171
4
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
provide additional feedback on the document.
Materials for the meeting have already been
provided to SRP members, are available to the public on
the OEHHA website. And the website is also noted. If you
haven't found -- well, presumably, if you're on the
website, you've already found this, but the documentation
is available on the web.
So let's start out with John Budroe or -- John.
DR. FAUST: I was just going to introduce John.
I'm John Faust, Chief of the Air, Community, and
Environmental Research Branch. And I'm just here to
introduce Dr. John Budroe, who's Chief of our Air
Toxicology and Risk Assessment Section, who will be giving
the continued presentation on the unit risk factor for
tertiary-butyl acetate.
So, John.
(Thereupon an overhead presentation was
presented as follows.)
DR. BUDROE: Good morning, Dr. Kleinman, Panel
members.
--o0o--
DR. BUDROE: I'll be -- this will be starting off
with a brief overline -- outline of the document. And I
can definitely promise you that you won't be subjected to
90 slides this time around.
J&K COURT REPORTING, LLC 916.476.3171
5
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
So the timelines for this document -- the initial
document was released for a 60-day public comment period
on August 14th, 2015. The Scientific Review Panel draft
was released to the public and the SRP November 14th,
2016. And the first Scientific Review Panel document
review was done on December 13th, 2016.
--o0o--
DR. BUDROE: Now, the changes that were made from
the initial version of the document in response to the
comments made by the Panel:
Potential residential and worker exposures were
added from Bus 2014. And non-cancer health effects
information was added. And these two sections are fairly
straightforward. And I won't be discussing them further
in the presentation. But if the Panel has questions on
them, I'd certainly be happy to answer them.
The metabolism section of the document was
expanded, including information on carboxylesterase
activity in humans and rodents, and methyl tert-butyl
ether, or MTBE, and ethyl tert-butyl ether, or ETBE, as
TBAc surrogates. Expanded survival data was added to the
bioassay section.
--o0o--
DR. BUDROE: There was a change from poly-3
correction to effective number of animals in cancer dose
J&K COURT REPORTING, LLC 916.476.3171
6
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
response analysis. And the effective number of animals is
the number of animals alive on the first day the tumor of
interest was observed in any dose group. And I'll be
expanding on that later.
--o0o--
DR. BUDROE: To get into the -- a little bit of a
refresh on the core part of the document. The metabolism
of TBAc, it's substantially metabolized to
tertiary-butanol, or TBA. That inhaled TBAc is rapidly
distributed to tissues. And metabolism occurs through
hydroxylation, hydrolysis, and/or glucuronidation.
--o0o--
DR. BUDROE: This is a slightly out of focus
metabolic scheme for TBAc. And one of the things that we
added to this were at the beginning of the metabolic
pathway the types of reactions that were occurring.
--o0o--
DR. BUDROE: And we added a expanded discussion
of the action of carboxylesterases. Bus suggested that
the hydrolysis of TBAc to TBA in rats is mediated by
carboxylesterases or CEs.
Human and mouse data for CE metabol -- mediated
metabolism of TBAc to TBA are not available. However,
there are a variety of CEs in both humans and mice, six
isoforms in humans, 20 in mice.
J&K COURT REPORTING, LLC 916.476.3171
7
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
And these CEs have a broad substrate specificity
and are distributed within a wide variety of tissues,
suggesting that this metabolic pathway could be operative
in both humans and mice.
--o0o--
DR. BUDROE: We also have a discussion of MTBE
and ETBE, especially MTB as a TBA surrogate. And MTBE is
metabolized to TBA in rats, mice, and humans after oral
and inhalation exposure. And is a carcinogen in both rats
and mice.
TBA also appears in the exhaled breath of humans
after both oral intake and inhalation exposure, suggesting
that MTBE lacks a significant first pass effect in humans.
The MTBE data suggests that TBA may also not experience
significant first-pass metabolism in humans. The MTBE
data also indicates that MTBE toxicity in humans is
probably independent of the route of exposure, which
suggests that TBAc toxicity in humans may also be
route-independent.
--o0o--
DR. BUDROE: Now, the TBAc cancer risk assessment
is based on the 2-year TBA drinking water study in rats
and mice that was done by NTP in 1995. The study
population was Fischer 344 rats and B6C3F1 mice. The
exposure method drinking water ingestion for up to 103
J&K COURT REPORTING, LLC 916.476.3171
8
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
weeks. In male rats, concentrations up to 5 milligrams
per ml. Female rats up to 10 milligrams per ml. And in
male and female mice up to 20 milligrams per ml.
--o0o--
DR. BUDROE: This is a listing of the tumor
incidences for the key tumor types in rats and mice:
Renal tubule adenomas and carcinomas in male rats, and
thyroid follicular cell adenomas in male and female mice.
And the 2.5 milligram per ml dose was statis -- the tumor
incidence for renal tubule adenomas and carcinomas was
significantly increased compared to controls.
In female mice, the high dose demonstrated
increased -- statistically significantly increased thyroid
follicular cell adenomas compared to controls. And this
call type is conceded to progress to carcinomas.
--o0o--
DR. BUDROE: So the critical effects were renal
tubule adenomas and carcinomas in male rats; thyroid
follicular cell tumors in female mice. And the male rat
kidney tumor data and female mouse thyroid data dose
response analysis was conducted using tumor incidences
adjusted for the effective number of animals.
--o0o--
DR. BUDROE: And this change -- this was
essentially a change from using a poly-3 correction in the
J&K COURT REPORTING, LLC 916.476.3171
9
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
prior version to effective number of animals in this
version. And as I stated earlier, the effective number of
animals is the number of animals alive on the first day
the tumor of interest was observed at any dose group.
Now, a poly-3 correction is generally used when early
mortality is observed in treated groups.
--o0o--
DR. BUDROE: And we went back and looked at the
data again. And early mortality was really not present in
male rats and female mice in the NTP 1995 study. And the
use of effective number of animals is pretty much standard
practice in the OEHHA cancer dose response analysis. In
fact, I sus -- believe that most, if not all, of the
animal bioassay derived cancer potency factor documents
that the Panel has seen has used effective number of
animals.
The change from the use of poly-3 correction to
the effective number of animals resulted in slight changes
in the TBAc inhalation unit risk, or IUR, and associated
slope factors.
--o0o--
DR. BUDROE: So this is the tumor incidences with
the prior poly-3 adjustment.
--o0o--
DR. BUDROE: And this is the increased tumor
J&K COURT REPORTING, LLC 916.476.3171
10
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
incidence adjusted for effective number of animals. And
the significance of the -- pairwise comparison
significance didn't change. You still had a positive
trend test for dose response.
--o0o--
DR. BUDROE: So we calculated cancer slope
factors for TBA using benchmark dose software. And a
cancer slope factor in animals for -- of 3.1 times 10 to
the minus 3 milligram per kilogram day to the minus 1 was
calculated from the male rat kidney tumor data set with
the high dose eliminated using a first degree polynomial.
--o0o--
DR. BUDROE: The reason that high dose was
dropped was to allow for model convergence. This is a
procedure that U.S. EPA acknowledges and feels it's
reasonable to do in those circumstances in their BMDS
guidance. And the first degree polynomial is used to
model the data for goodness of fit purposes.
We also calculated a TBA cancer slope factor of 8
times 10 to the minus 5 milligram per kilogram day from
the corrected female mouse thyroid tumor data set using a
third degree polynomial multi-stage cancer model.
--o0o--
DR. BUDROE: The male rat kidney tumor data
yielded the highest cancer slope factor value. And we
J&K COURT REPORTING, LLC 916.476.3171
11
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
then converted this animal cancer potency estimate to a
human potency equivalent. And this was done -- this
conversion was done using a body weight to the
three-quarter power scaling.
--o0o--
DR. BUDROE: So the TBA cancer slope factor for
humans was found -- was calculated as 1.1 times 10 to the
minus 2 milligram per can kilogram day to the minus 1.
--o0o--
DR. BUDROE: We then derived a TBA -- a TBAc oral
cancer slope factor of 5 times 10 to the minus 3 milligram
per kilogram day to the minus 1 from the TBA human cancer
slope factor, assuming a TBAc to TBA metabolic conversion
factor of 0.71, and a molecular weight ratio, or MWR, of
0.64, which is the ratio of the TBA molecular weight to
the TBAc molecular weight.
--o0o--
DR. BUDROE: A TBAc inhalation cancer slope
factor was then calculated from the oral slope factor
using the equation below where fractional absorption is 95
percent.
--o0o--
DR. BUDROE: A TBAc unit risk factor was then
derived from the inhalation cancer slope factor using a
human breathing rate of 20 cubic meters per day, an
J&K COURT REPORTING, LLC 916.476.3171
12
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
average human body weight of 70 kilograms, and a milligram
to microgram conversion of 1000. And this yielded a
unit -- inhalation unit risk of 1.3 times 10 to the minus
6 micrograms per cubic meter to the minus 1. So
essentially this means that you have -- if you're exposed
to a concentration of 1 microgram per cubic meter of TBAc,
the corresponding cancer risk is 1.3 in a million.
--o0o--
DR. BUDROE: So the prior document version had
oral slope factors and inhalation slope factors of 7 and
6.7 times 10 the minus 3 milligram per kilogram day to the
minus 1 respectively, and an inhalation unit risk of 1.9
times 10 to the minus 6 microgram per cubic meter.
The current version has oral and inhalation slope
factors of 5 and 4.7 times 10 to the minus 3 per milligram
kilogram day to the minus 1, and an inhalation unit risk
of 1.3 times 10 to the minus 6 microgram per cubic meter
to the minus 1.
So as you can see, the change from poly-3
correction with effective number animals did not make that
much of a difference in the final slope factors in
inhalation unit risk values.
--o0o--
DR. BUDROE: Now, we also have a response to the
LyondellBasell March 2, 2017 letter to the SRP. And we
J&K COURT REPORTING, LLC 916.476.3171
13
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
reviewed the contents of the letter. And there wasn't
anything in there to justify revising the document in
response to the letter contents, but we did prepare
responses for the Panel.
These are not exact quotes, but I've paraphrased
what was in the letter for the presentation. And Lyondell
commented that neither the SRP nor the Proposition 65
Cancer Identification Committee, or CIC, have previously
reviewed either TBAc or TBA for carcinogenicity. And the
only cancer slope factor approved by the SRP for a
chemical not previously designated as a carcinogen by an
authoritative body, for example IARC, was MTBE.
The OEHHA response to this is that TBAc and TBA
have indeed not been previously reviewed for
carcinogenicity by either the SRP or CIC or designated as
a carcinogen by authoritative body.
However, neither review by the CIC nor
authoritative body, carcinogen designation is required for
the SRP to determine that the chemical is a carcinogen.
PANEL MEMBER GLANTZ: Aren't we considered an
authoritative body for that?
DR. BUDROE: An authoritative body is kind of
Proposition 65 language. So it's like NTP, IARC, U.S.
EPA. There's also -- we'll get to talking about the
State's qualified experts, and that's its own also
J&K COURT REPORTING, LLC 916.476.3171
14
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
designation lives in its own place.
--o0o--
DR. BUDROE: Another Lyondell comment was that a
pathology working group or PWG that was published --
PANEL MEMBER GLANTZ: I just happened to notice,
did you get an email from Kathy Hammond?
PANEL MEMBER BLANC: Yes. Yeah, she's listening.
Kathy, glad you're listening. Our system is not allowing
you to speak.
Kathy, sorry. I know your listening. I believe
you're listening. When the system allows you to speak,
please chime in, even if you're interrupting someone.
PANEL MEMBER GLANTZ: But you have to turn on
your microphone they said.
I'm sorry, but --
DR. BUDROE: So the PWG that was published in
Hard 2001(sic) reviewed the 1995 NTP male rat kidney
pathology slides and concluded that alpha
2u-globulin-induced nephropathy and chronic progressive
nephropathy, or CPN, exacerbation were the only causative
factors in the development of renal tubule tumors observed
in males rats exposed to TBA in drinking water. And they
felt that the -- they said that the PWG concluded that
TBA-related renal changes in rats could not be
extrapolated to human health risk assessment and were
J&K COURT REPORTING, LLC 916.476.3171
15
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
unlikely to pose any risk for humans.
Our response is that we reviewed the Hard 2011
article. We discussed some of its conclusions in the
prior version, the initial version, of the cancer hazard
evaluation section of the document. However, OEHHA
disagrees with the conclusions of Hard et al., based on
data from Doi et al., 20 -- 2007, and Melnick et al.,
2012, as was discussed in the document.
--o0o--
DR. BUDROE: Another Lyondell comment was that
OEHHA's proposed cancer slope factor for TBAc is based
solely on their speculation that TBA, the primary
metabolite of both TBAc and MTBE, is a genotoxic human
carcinogen.
The OEHHA response is that the proposed TBAc
cancer slope factor is based on a dose response analysis
of the NTP 1995 TBA drinking water study. OEHHA did not
state in the document that either TBAc or TBA are
genotoxins, and does not propose a mode of action, or MoA,
for TBA carcinogenicity.
However, given the limited positive genotoxicity
data for TBA, it cannot be stated that TBA is not a
genotoxicant. And this is significant to determining if
TBA meets the IARC criteria on whether chemicals induce
male rat kidney tumors through increased accumulation of
J&K COURT REPORTING, LLC 916.476.3171
16
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
alpha 2u-globulins.
--o0o--
DR. BUDROE: Another Lyondell comment was that
the reason that OEHHA developed an interim risk factor for
TBAc, based on the 1995 TBA chronic study, was because
ARCO Chemical requested that the Air Resources Board grant
a VOC exemption for TBAc, based on its negligible
ozone-forming potential.
Our response is that the prior interim TBAc
cancer inhalation unit risk factor was developed at the
request of ARB, because of a VOC exemption request that
was made by Lyondell Chemical Company on February 28th,
2000.
--o0o--
DR. BUDROE: A Lyondell comment. The interim
cancer risk factors developed by OEHHA in 1999 and 2000
for TBA and TBAc were never sanctioned by CIC or reviewed
by the SRP.
And the OEHHA response is that interim cancer
slope factor and unit risk for TBAc was not reviewed by
the SRP, because these values were not intended for use in
the Air Toxics Hot Spots Program. The CIC has no
statutory authority to review or sanction hot spots or VOC
exemption cancer risk factors.
--o0o--
J&K COURT REPORTING, LLC 916.476.3171
17
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
DR. BUDROE: Another Lyondell comment was that
Lyondell requested a formal evaluation of the risk factors
in 2011 and a peer review by the State's qualified
experts, i.e. the CIC or SRP.
And the OEHHA response is that TBAc was entered
into the hot spots evaluation process at the request of
several air districts. Any development of either RELs or
cancer risk factors would then be peer reviewed by the
SRP. The CIC are the State's qualified experts for the
purposes of Proposition 65, and has no authority to review
peer review -- the peer review evaluations conducted under
the Hot Spots Program.
--o0o--
DR. BUDROE: Another Lyondell comment was that
OEHHA failed to engage the CIC in resolving the scientific
adequacy of the interim cancer risk factor assumptions.
Lyondell's concern that OEHHA has not allotted adequate
time for meaningful independent review and public comment,
and is now asking the SRP to make a determination of
carcinogenicity that is normally the purview of the CIC.
And the OEHHA response to that comment is that
Lyondell misunderstands the role of the CIC which are the
State's qualified experts for Proposition -- for the
purposes of Proposition 65.
The CIC does not have the statutory authority to
J&K COURT REPORTING, LLC 916.476.3171
18
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
review hot spots documents. The SRP is the entity that
has statutory responsibility to peer review hot spots
documents. And OEHHA believes that the time provided for
public comment and the SRP review was adequate.
--o0o--
DR. BUDROE: And that concludes my presentation,
and would happy -- be happy to entertain any questions
from the Panel.
CHAIRPERSON KLEINMAN: Okay. Thank you, John.
I understand that Beate and Kathy are able to
hear the proceedings, and we are now going to try to
arrange for them to be able to voice in on the meeting.
So we'll take a 5-minute break before we start with the
Panel discussion to allow the technical people to do that.
PANEL MEMBER GLANTZ: I just got another email
from Kathy that says, "I am listening. I will announce
myself when my oral capacity appears".
(Laughter.)
(Off record: 10:47 a.m.)
(Thereupon a recess was taken.)
(On record: 10:53 a.m.)
CHAIRPERSON KLEINMAN: I'd like to reconvene the
meeting now. And before we go on with the questioning,
I'd like to give Kathy Hammond and Beate Ritz an
opportunity to just introduce themselves.
J&K COURT REPORTING, LLC 916.476.3171
19
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
So start with you, Kathy.
PANEL MEMBER HAMMOND: Hi. I'm Kathy Hammond at
UC Berkeley, professor Environmental Health Sciences. And
one of my specialties is exposure assessment.
CHAIRPERSON KLEINMAN: Thank you.
PANEL MEMBER RITZ: And this is Beate Ritz. I'm
a professor of environmental epidemiology with the Center
of Occupational and Environmental Health at UCLA.
CHAIRPERSON KLEINMAN: All right. Thank you. So
we'd like to now go on to the next phase of the meeting,
which will be to have the Panel members discuss the
revised document.
John.
DR. BUDROE: Dr. Kleinman, I'd like to introduce
a member my staff, Dr. Rona Silva. She's one of the
co-authors on this document, along with Dr. Kathy Vork.
And she'll be possibly answering some of the questions on
the exposure assessment and non-cancer toxicity section of
the document.
CHAIRPERSON KLEINMAN: Thank you.
So I'd like to start with did Araujo who's the
lead on the discussion, and then we'll continue from
there.
PANEL MEMBER ARAUJO: Thank you, Dr. Kleinman.
Thanks so much for the -- for all the work and -- that has
J&K COURT REPORTING, LLC 916.476.3171
20
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
been invested on reviewing these documents, and also in
the presentation with the summary of the changes.
The review was very extensive. And overall, I
have to say that I am very pleased with all the work that
was done. There were several points and issues that were
critiqued. And I think that pretty much on all of them -
I don't know if I am missing anyone - were addressed.
It has been strengthened and there are like new
sections that are described in the summary of changes.
The whole exposure sections in the beginning is new with
tables and new studies.
There was a critique about the study -- the
document not being updated and not including recent
studies. And certainly, there is now an effort in
including all the new studies, including studies that were
published this year.
And several figures were critiqued, several
tables were critiqued, and -- in the way how they were
presented, and those changes were included.
If anything, I would have to say that the summary
of changes was a little bit shy for everything that was
done in the document. And I understand that it was in the
interests of not making the presentation too extensive.
But in the future, maybe you can -- you can go along and
show everything that you did, because I think that it --
J&K COURT REPORTING, LLC 916.476.3171
21
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
and for -- and those who didn't read the document and --
in detail as it would have been helpful to read and
understand why is that you did many of the changes that
you did.
The metabolized section was also expanded and
strengthened. So I'm very pleased with that. And I think
that I -- even myself have a better understanding from
reading the document of what is -- what the TBA and dose
and how it's metabolized.
I do have a question. It's about one of the
changes that you did. I didn't quite understand the
decision that you made and why. It was on the -- on Table
17. On Table 17, you omitted -- in the original
presentation of the table, which corresponded to another
number. You had presented the data for the male mice, and
that you decided to remove that data entirely. I don't
know why. What was that decision made?
DR. BUDROE: It was simply that we were
presenting the tumor incidences where we did adjust it for
effective number of animals. And since the male mice were
being considered for cancer dose response analysis, we
decided it was not necessary. It's just essentially extra
data. So we pared it down to the key species and tumor
types that we were developing the dose response analysis
on.
J&K COURT REPORTING, LLC 916.476.3171
22
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
PANEL MEMBER ARAUJO: Okay. So that was -- that
is -- exemplifies one of the cases in which obviously you
don't need to make an explanation in the document why you
made that decision, but in the summary of changes, as you
could have shown it. And that explain it by itself.
I also agreed with the essence of your responses
and -- to the letters. And I believe that your
explanations of why con -- what to consider TBAc as a
carcinogen, just based on the data derived from the
metabolites. I think that it was reported and -- in the
document, as well as in the way how you responded to the
letter and writers.
CHAIRPERSON KLEINMAN: Okay. Thank you.
I did not have too many substantive changes, most
of my comments were very well addressed. Thank you for
that. And one thing just reading the document,
there was -- you know, it -- the shift in terminology from
unit risk factor to inhalation unit risk, and then in the
headings it's inhalation unit risk factor. I think it
should be one or the other.
DR. BUDROE: Yeah. And we changed that in the
current version, because we took a look at the guidance
manual and the appendices in there. And what you see in
the actual Hot Spots Guidance Manual is inhalation unit
risk. So -- and it's -- I went back and looked over some
J&K COURT REPORTING, LLC 916.476.3171
23
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
of the prior cancer documents, and they've really used
both. There hasn't been -- there wasn't necessarily
standardization, but we're going toward -- looking to
standardize on cancer inhalation unit risk, or IUR.
CHAIRPERSON KLEINMAN: Yeah, I think it would be
good to, yeah, just make sure that that's clear in the
document, because, you know, people will start to look for
two different things. And I have a few minor things which
I'll give you in writing, you know, just minor changes.
The other thing that was sort of alluded to y
Lyondell is that when some of these other agencies declare
something -- you know, a substance to be a carcinogen,
they have categories, you know, a known human carcinogen,
a suspected human carcinogen. You know, they have various
gradations.
And in this particular application for this
purpose, we're not assigning anything like that, is that
correct?
DR. BUDROE: That is correct.
CHAIRPERSON KLEINMAN: So our declaration of
carcinogenicity will be seen as different than say an IARC
designation or an EPA designation?
DR. BUDROE: That is correct.
CHAIRPERSON KLEINMAN: But that is within the
purview of the statutes in California, is that correct?
J&K COURT REPORTING, LLC 916.476.3171
24
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
DR. BUDROE: That is also correct.
CHAIRPERSON KLEINMAN: Okay. I just wanted to
make sure we're all on the same page on that.
All right. Then I'd like to start with Dr.
Buckpitt, who had some overall comments, and then some
minor comments that he's given me in writing and I'll pass
on.
PANEL MEMBER BUCKPITT: Yeah, thanks. These are
all really minor comments. Again, I'd like to say that I
thought you did a really good job making the case for
using TBA as your standard. You went through all of the
data, looking at the metabolism and how much is
metabolized in the various species. I thought you did a
very good job essentially blunting the comment that this
is all driven by alpha 2-microglobulin. So I think in
that respect, this is a well done document.
I had just a couple of things. When you have
Figure 4 and -- unfortunately, I didn't put the page
number down. But Figure 4 seems late in the document. If
you could move that up -- I think it was on page 10. And
this is on the metabolism of MTBE.
DR. SILVA: Which?
PANEL MEMBER BUCKPITT: Fourteen, yes.
DR. BUDROE: Okay. So you'd like that moved to
the front of section --
J&K COURT REPORTING, LLC 916.476.3171
25
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
PANEL MEMBER BUCKPITT: Moved forward, so that
when we read the paragraph -- I mean, I was sitting there
saying, oh, geez, did I have to go to the literature -
shame on me - to actually see how this is? And you had it
in there. Just move it forward, so that it's easily
accessible.
DR. BUDROE: Okay. We can certainly do that.
PANEL MEMBER BUCKPITT: And then lines 328
through 335, you talk about the metabolites of MTBE and
microsomal cytosolic Incubations. I presume those are the
same metabolites. It wasn't specifically stated. But if
you really look at the data, they cytosolic fraction is 1
percent or less of the microsomal fraction. I think it's
a waste of time to even mention it. Those are microsomal
metabolites.
I'm guessing that the data that 1 percent that --
or less that is there is probably contamination of the
cytosolic fraction from microsomes. People aren't
careful, they get microsomes in their cytosolic fraction.
DR. BUDROE: Okay. Well, that's not a critical
section, so we could easily delete that.
PANEL MEMBER BUCKPITT: Absolutely not.
The lines 362 through 367, I think it might be
useful to comment that the total metabolites include both
the conjugated and unconjugated. Going back to the paper,
J&K COURT REPORTING, LLC 916.476.3171
26
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
they actually used acid hydrolysis to cleave the
glucuronides.
DR. BUDROE: Okay. We can provide mention of
that.
PANEL MEMBER BUCKPITT: Line 373, you have C-13
labeled as a radioactive isotope, but that's just a stable
isotope. And again, it's a minor comment.
The only other two comments so line 912, 913, the
authors were evaluating adducts by using accelerator mass
spectrometry. I would actually use adducts rather than
damage, because damage can essentially be the result of
oxidation of DNA basis, and I'll defer to Dr. Landolph if
he disagrees.
And then line 1182 you have
8-hydroxy-deoxyguanosine as not an adduct at base. It's
really an oxidized base. But it's just terminology.
And I have a few other things, but none of them
are critical at all. So good job.
DR. BUDROE: Thank you.
CHAIRPERSON KLEINMAN: Stan.
PANEL MEMBER GLANTZ: Since this is almost all
toxicology, I'll defer to my colleagues to know what
they're talking about.
PANEL MEMBER BLANC: Any comments on the
statistical analysis in terms of the tumor incidence
J&K COURT REPORTING, LLC 916.476.3171
27
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
since -- in the oral comments, it talked about pairwise
comparisons, but then talked about trend. And it was not
entirely clear how the appropriate trend was being used
when I looked at it.
PANEL MEMBER GLANTZ: Well, yeah, actually, now
that you mention it, I had noted that. So I think -- I
think in the tables, let me -- there are two tables where
you have those data, which were -- I'm -- well, do you
know the two tables I'm talking about? Yeah.
DR. BUDROE: I believe so.
PANEL MEMBER GLANTZ: Yeah, I think it would have
been a better idea -- I'm sorry, I spaced out. I don't
think it's going to change anything in the report, but I
think it would have been better to have tested for a trend
in the data, rather than just do a bunch of pairwise
comparisons, which is what you did.
DR. BUDROE: Well, it -- I looked at that pretty
exhaustively --
PANEL MEMBER GLANTZ: Okay.
DR. BUDROE: -- and what you're -- this is
essentially the pairwise comparisons are for the hazard ID
section of the document, is this or is this chemical -- is
it or is it not a carcinogen.
And NTP in pretty much every cancer hazard ID
document I've ever seen, they used to use chi-squared
J&K COURT REPORTING, LLC 916.476.3171
28
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
comparisons. Now, they that use Fisher Exact. And you
can get a trend test, Cochran–Armitage, out of -- if you
run the data through the data through BMDS, for example.
But it's essentially Fisher Exact is the gold standard.
So where we would go, you know, other than that, I'm
really not quite certain.
PANEL MEMBER GLANTZ: Well, I guess -- well, no,
but the -- I mean, they're not incompatible. But as long
as you think that things -- as the exposure goes up, the
incident -- the tumor incidence goes up, why you -- can't
you just test it against dose, or is it the numbers are
too small?
DR. BUDROE: Well, we just -- it's -- we're using
the Fisher Exact just to determine if the chemical is a
carcinogen or not. Those -- that doesn't enter into the
cancer dose response analysis.
PANEL MEMBER GLANTZ: Right. Right. But what
I'm -- what -- I mean, the point Paul made up is when
you're doing the pairwise comparisons with Fisher Exact
tests or chi-squared depends on what the -- how big the
numbers are.
You're -- you -- that has less power actually,
the testing for a trend, because when you're looking at
the pairwise comparisons, you're only looking at part of
the data in each comparison, whereas if you test for a
J&K COURT REPORTING, LLC 916.476.3171
29
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
trend, you're using all the data at once. So that's going
to give you more power to detect an effect.
I mean, you detected an effect, even using the
less powerful approach, so I don't think it substantively
changes the document.
But I -- I was sort of surprised you didn't do a
trend test. I mean, if you wanted to keep the pairwise
comparisons, there's nothing -- you could, but I think you
could -- the thing would be stronger, I mean, if you were
to show that there is a trend in -- between -- as the dose
goes up. I'm not talking about using it to quantify a
particular dose-response relationship.
DR. BUDROE: We do include tend trests -- tend
trests --
PANEL MEMBER GLANTZ: Trend tests.
DR. BUDROE: -- trend tests results for --
PANEL MEMBER GLANTZ: I didn't see the --
DR. BUDROE: -- both tumor types.
PANEL MEMBER GLANTZ: Well, maybe I missed it,
but I didn't see it in those two tables.
PANEL MEMBER BLANC: I don't believe it was in
the footer of the tables Was it somewhere buried in the
text?
PANEL MEMBER GLANTZ: Yeah, because I went
through this and -- I'm just trying to find the tables.
J&K COURT REPORTING, LLC 916.476.3171
30
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
DR. BUDROE: Table 17.
PANEL MEMBER BLANC: Are you talking about
what --
DR. BUDROE: Yeah, we actually note there was a
significant trend test for dose response in the female
mouse thyroid follicular cell adenomas. And that's in
footer of the table.
PANEL MEMBER GLANTZ: Oh, okay. I was actually
thinking maybe that -- okay. I was actually thinking
about a couple table -- earlier tables. But maybe
that -- that wasn't -- let me see if I can find them. I
don't think this materially affects the report. That's
why I didn't mention it. Let me see if I can find where
it is.
DR. BUDROE: Yeah, we also mention it in Table
10, where we have the uncorrected tumor incidences. We
include the trend test in the footer also.
PANEL MEMBER GLANTZ: I guess, the one -- Oh,
okay, the one -- wait. Well, that wasn't it. Hang on.
Maybe I'm missing it here.
PANEL MEMBER BLANC: I think our confusion
relates to the earlier table that presents the same animal
data, but not reduced. I mean, this is a synopsis, right,
Table 10, but doesn't the same animal study appear earlier
in the document? Separately for the renal tubules and
J&K COURT REPORTING, LLC 916.476.3171
31
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
then the thyroid, is that not correct?
PANEL MEMBER GLANTZ: You know, that -- I have to
say, Paul, now that I'm looking at one more place --
DR. BUDROE: We have the trend test results.
PANEL MEMBER GLANTZ: Yeah, just let me -- I
think. I think what happened -- let me -- because the
reason I didn't say anything -- now that I look back at my
notes here, is that as I was reading it, I had that
question, but then you answered it.
So they actually did do the -- the stuff he's
talking about they did in the revised version.
PANEL MEMBER BLANC: Got you.
PANEL MEMBER GLANTZ: So I -- yeah, so I was like
going through -- I'm just looking at my notes where I said
why didn't they do this. But then I went on an found you
did it, so never mind.
(Laughter.)
PANEL MEMBER GLANTZ: So I'm happy.
(Laughter.)
CHAIRPERSON KLEINMAN: Thank you.
PANEL MEMBER GLANTZ: That's why I thought I was
happy, but then Paul got me all confused.
(Laughter.)
PANEL MEMBER BLANC: It's all my fault.
(Laughter.)
J&K COURT REPORTING, LLC 916.476.3171
32
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
PANEL MEMBER GLANTZ: Everything is always your
fault.
CHAIRPERSON KLEINMAN: Paul, did you have any
additional comments?
PANEL MEMBER BLANC: I want to make sure I
understand the rational argument here just for my own
edification. So the argument is -- or the way of
addressing the challenge of the lack of data is that the
metabolite of this chemical in small animal tests is a
chemical which has been shown to be carcinogenic as per
the tables we were just talking about. There's no human
metabolic data for this chemical, and therefore by
analogy, you rely on the metabolic data for MTBE, for
which there is human data, and the presumption that since
the enzymatic pathway relies on metabolic enzymes that are
present in humans, it's a reasonable presumption that
the -- that the chemical would be metabolized to the same
carcinogen, is that correct?
DR. BUDROE: That is correct. And especially
since in rats the bulk of the TBA production is going to
be through carboxy -- carboxylesterase activity. And
there's, you know, numerous CEs in humans, and they have a
broad -- they're not narrowly specific, they're broadly
active.
PANEL MEMBER BLANC: Right. So --
J&K COURT REPORTING, LLC 916.476.3171
33
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
DR. BUDROE: So it's -- we believe it's a
reasonable assumption to make that that same thing is
going to happen -- process is going to happen in humans.
PANEL MEMBER BLANC: So I think at least in your
summary, but elsewhere, it would be perhaps more
conservative to say the presumptive human metabolite or --
because you -- what you state is it's metabolized to
this -- this entity, this moiety, but, in fact, it's
metabolized in rodents to that moiety, and presumptively
also in humans. So I think that just for -- it would be
better science if the word "presumptive" was inserted
strategically.
DR. BUDROE: Okay. We can do that.
PANEL MEMBER BLANC: And then I have a very
quirky question, which may be absurd, but there were
tertiary-butyl acetate ester pharmaceuticals on the
market, steroids specifically. And I just was wondering
was there never any data filed with the FDA on the
metabolism of that? It may be more than one
pharmaceutical, but the one I know about is prednisolone
one of the corticosteroids was or may still be marketed as
the tertiary-butyl acetate ester. Did you ever look at
that or hear about that?
DR. BUDROE: We didn't pull it up on any of our
literature searches. And sometimes some of that -- some
J&K COURT REPORTING, LLC 916.476.3171
34
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
of the FDA filing data can be pretty difficult to acquire.
PANEL MEMBER BLANC: Yeah, I just think it would
be -- I mean, because so much of this -- you know, you're
forced, from the lack of data, to go down this route,
which I'm not saying is unreasonable, but it would be
really nice to be able to either say there is some data
from that, or there's no data for that either.
I don't want to hang up the document on that, but
I was just -- and I could be completely wrong that that's
what it's called, but it's not really an ester of that.
It -- just looking at it quickly, it seemed to be that's
what that was.
DR. BUDROE: We can take a look and see if
there's any data out there that we can get a hold of in
that respect.
PANEL MEMBER BLANC: And similarly on the lack of
data front, there are two -- there's a statement that's --
I understand why you said it, but it's somewhat, on the
face of it, contradictory, which is you say that there's
no occupational data. Which is true in the sense of I
couldn't at least find any work-related investigations.
And then you quote occupational exposure data, which is
based on ILO statements or something.
But I think you have to use some wording which
makes clear what you mean when you say there's no
J&K COURT REPORTING, LLC 916.476.3171
35
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
occupational data, like there's no occupational data
that's -- there's no published occupational data on
specific work-site investigations or case reports or
whatever. That it's -- somebody came up in the ILO with
these statements about what happened, it's irritating,
it's this, it's that, right? But you don't have any -- we
don't know if that was personal communications or what --
where is that derived from.
But still, you can't on one page say there's no
occupational data and then on another page say the
occupational exposures are associated with X, Y, and Z.
DR. BUDROE: We can make it clearer that what
we're referring to is we haven't been able to find any
occupational studies published.
PANEL MEMBER BLANC: Well, any specific -- some
wording that makes it clear what it is you mean when --
DR. BUDROE: Right. We'll -- we'll endeavor to
clarify that.
PANEL MEMBER HAMMOND: Yeah, I also --
PANEL MEMBER BLANC: Because it must be --
PANEL MEMBER HAMMOND: Yeah, I don't want to
interrupt except but I am, of course.
I think -- I have several comments on the
occupational data. But I don't know if you want to do
this in topics or just go around to the people. I defer
J&K COURT REPORTING, LLC 916.476.3171
36
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
to you, Michael.
I can't hear you.
PANEL MEMBER GLANTZ: I had one --
CHAIRPERSON KLEINMAN: Kathy. Yeah, we can hear
you. Stan has another comment that he wanted to interject
and then we'll pass the baton to you.
PANEL MEMBER HAMMOND: Okay. Thank you.
PANEL MEMBER GLANTZ: Just to show that I did
read it. Actually, you have the name of that office
wrong. It's the International Labor Organization not
Office. So that's on line 199 of the track changes
version.
CHAIRPERSON KLEINMAN: Paul, did you have
anything further?
PANEL MEMBER BLANC: No. Those were my salient
points.
CHAIRPERSON KLEINMAN: Thank you.
Okay. Kathy, I'll pass the baton to you.
PANEL MEMBER HAMMOND: Okay. I guess I'm looking
at Table 1, and I'm looking at versions of tracks just for
clarity.
I think that there -- for me, there are things
that make it difficult to understand. Like there's an
expression here, "near source". It took me a couple times
looking at it to realize when we say near source, you mean
J&K COURT REPORTING, LLC 916.476.3171
37
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
as a worker who's right there working with something? And
then far source means that they're across the room. And I
think here near source means out environmentally near the
building in which the material shoots, is that correct?
DR. BUDROE: That's correct.
PANEL MEMBER HAMMOND: Yeah. So I think that
that probably should be clarified. I don't know, I would
rather -- rather than putting near source, I'd say
something like near a building or where it's being used,
because otherwise it's just -- there's a whole other
research area that does -- uses different terminology.
And then if you look at the first two lines of
data 1 hour concentration, and it's the big -- and these
are really modeled exposures not measured, as I understand
it, is 269 ppb, whereas being near source, which means an
environmental exposure. And I'm not sure how near that
is, if the paper tells you that. But if it does, we
should put that in, like 50 feet away or whatever it is.
But that must be some particular distance and
that should be in the -- defined there. That's higher.
That doesn't make sense. Occupational exposure is less
than far from use.
DR. BUDROE: Okay. Well, we do, to some degree,
define what a near-source concentration is in the figure
legend. Near source concentrations were estimated at the
J&K COURT REPORTING, LLC 916.476.3171
38
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
facility fence line are 20 to 30 meters from the point
source, unless otherwise noted.
PANEL MEMBER HAMMOND: Yes. So, you know, I
would say 20 to 30 meters from the facility. So like, you
know -- or just facility -- but I wouldn't call it near
source, because near source, in my world, means that
you're using the material directly, okay? And I don't
think we should mix those things.
But then secondly, there's just these values
don't make sense. You've got a consumer having -- these
first three acute exposure scenarios do not make sense,
and --
DR. BUDROE: Right. Well, this was taken from
Bus 2014, and it's a compilation of a number of different
modeling es -- modeling scenarios. And we don't really
vouch for whether they did these correctly or not. We're
just essentially reporting what was published in the
literature. So, you know, if you went and looked at --
went back and looked at the modeling assumptions, I can't
guarantee that they do make sense, but, you know, this is
what --
PANEL MEMBER HAMMOND: Yeah, but if you were --
if you were looking at a toxicity study, and you saw a
fatal flaw in how they did something, you would note it,
you know, or you might even choose not to use it. I don't
J&K COURT REPORTING, LLC 916.476.3171
39
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
think that just copying what's in the literature is
appropriate. You know, this may include assumptions of
using respiratory protection. I have to assume that
that's what's there, but it doesn't say that, and I'm not
totally convinced that in all auto repair shops that they
actually use respiratory protection. And if they do, that
it's effective respiratory protection.
There may be implicit respiratory protection, you
know, assumptions here, but it's not. And it is mentioned
below that everybody does it, but I'm not sure everybody
does it. And if they do, it's probably paper masks that
are not all that effective.
So beyond that, I -- since most of these things
are not -- I think there should at least be an indication,
are all of these measured -- or, I mean, calculated --
just estimates calculated or are they measured?
And if they're estimated calculated, several of
these things just -- you know, they're too -- they're not
different enough to be worth anything. If they're
actually measured, then that's useful.
DR. BUDROE: Well, they are all modeled
concentrations. We do mention in the figure legend that
we were only able to confirm the model concentrations
attributed to ARB.
PANEL MEMBER HAMMOND: And -- yeah. Anyhow, I
J&K COURT REPORTING, LLC 916.476.3171
40
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
just am concerned that the occupational level is
tremendously underestimated. Perhaps there could be in
the scenario listed at least an indication which of these
scenarios are measured values, as opposed to calculated.
DR. BUDROE: Okay. Well, then none of them are
measured. They're all calculated.
PANEL MEMBER HAMMOND: That's what I thought.
Yeah.
DR. BUDROE: We could make that more explicit in
the text.
PANEL MEMBER HAMMOND: Right. Yeah. Well, as I
say, I don't -- and this is a minor thing, but in the
acute exposure scenarios, if you're going to use
scientific notation, use scientific notation. So, for
instance, rather 461 times 10 to the 3rd, I'd suggest 4.61
times 10 to the 5th, because at first it's a little
jarring to see the microgram per cubic meter to ppb.
But I really do have to say I don't believe the
occupational number. And these chronic exposure
scenarios, these are all environmental, correct? None of
these are occupational, if I understand it.
Oh, I see. Then it's occupational down here.
But the near source should be, you know, again made
clearer, which ones are -- that it's at the facility fence
line or 20 to 50. Near the facility would be better than
J&K COURT REPORTING, LLC 916.476.3171
41
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
near source. Maybe that would be the simpler way to put
it. And then have the footnote, you know, at that point,
where you do talk about it in -- I know it's down there in
the footnote. I read that.
But again, the occupational numbers, the first
couple are not credible. And then you look at the others,
and they begin to be credible. So I don't even know what
they're doing there. How they get those -- those
scenarios. I did not go back to the original paper, but I
have difficulty believing those values. Is Kathy Vork
there? Maybe she can answer that.
DR. BUDROE: Kathy Vork is present, but she
didn't work on this section of the document.
PANEL MEMBER HAMMOND: Oh, okay.
DR. BUDROE: Rona Silva did. She's here at the
table.
PANEL MEMBER HAMMOND: Okay. Anyhow, those were
my concerns. I don't know did anybody actually take a
careful look at this table, or is it just kind of put in?
I believe it's a little misleading.
CHAIRPERSON KLEINMAN: John, let me ask, when you
have numbers with these kinds of disparities, you know,
how are those scenarios, you know, played into your final
determinations?
DR. BUDROE: It doesn't play into our final
J&K COURT REPORTING, LLC 916.476.3171
42
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
determinations at all. This is really just more
informational. I mean, actually the comment was made by
the Panel at the last meeting that we should include some
of the exposure scenario information that Bus published.
And he in turn pulled it from a number of different -- I
think developed some of it himself, and the bulk of it was
developed by different air districts or ARB. So we
included it essentially in the front part of the document
as informational item. But it actually won't go into the
appendix B part of the cancer TSD.
CHAIRPERSON KLEINMAN: Okay. It might be worth
putting in a sentence to that effect --
DR. BUDROE: Okay.
CHAIRPERSON KLEINMAN: -- that, yeah, these are
here for informational purposes to give, you know, an idea
of the range of potential exposures based on models.
DR. BUDROE: We can do that.
PANEL MEMBER HAMMOND: Okay. That's all. As I
say, I would rather see, if you don't think it's too
distorting of what Bus said, rather than "near source",
maybe call it "near facility".
DR. BUDROE: We can do that.
CHAIRPERSON KLEINMAN: Okay. Beate, did you have
any comments?
PANEL MEMBER RITZ: No, I'm fine. Thank you.
J&K COURT REPORTING, LLC 916.476.3171
43
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
CHAIRPERSON KLEINMAN: Thank you.
Cort.
PANEL MEMBER ANASTASIO: No, I didn't have any
comments either.
CHAIRPERSON KLEINMAN: Joe, I know you've --
knowing you, you probably did take a look at the document.
Do you have any comments?
PANEL MEMBER LANDOLPH: Yeah, I did. I read it
fairly carefully. And I wanted to congratulate the
authors and their team, which I think did a very strong
job, very thorough job of putting the document together.
I think they answered SRP's comments in a fair spirit of
peer review, and they answered the Lyondell comments in a
fair spirit of peer review.
So I thought the document was written in a fairly
balanced fashion, and I agree with most of its comments.
I was looking at the TA102 data, and I could see
there was a little bit of variability from lab to lab
there. One lab says yes, one lab says no. So clearly,
the genotoxicity is still not completely nailed down. And
that's okay. That's fine.
And I agree that it is a carcinogen and can be
treated as such, and that you can make calculations like
you've done. So I came into this in mid-stream, so I'm
not as critical as the rest of you, but I think the
J&K COURT REPORTING, LLC 916.476.3171
44
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
document is petty good.
CHAIRPERSON KLEINMAN: Okay. Thank you.
So I think that's -- everybody has had an
opportunity to provide some additional comments.
I do have a few things in writing that I will
pass on. But just to poll the Panel, does anybody feel
that there are any major issues that would require the
document to come back before the Panel?
Okay. The answer to that was no.
Therefore, what I'd like to do is ask for a
motion to request that the document be revised according
to the comments that we provided today. And that if the
Panel will give me the purview to do this, I'll have the
document returned to me. I will just go through it and
make sure the comments have been dealt with, and then we
will be able to call the case closed, because the State
law requires that the agency, OEHHA, seeks our advice and
recommended changes. And I think that by have -- you
know, once we have these final changes in, the Panel will
have fulfilled its statutory obligations, and so I'd like
to ask for a motion to do that.
PANEL MEMBER ARAUJO: I have just one comment
and -- prior to that, that is in relation to the point of
the near source as Kathy was alluding to. So I'm not an
expert on this by any reasons. I'm just trying to
J&K COURT REPORTING, LLC 916.476.3171
45
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
understand your point of view, Kathy. So if it is a -- so
is it universally accepted let's say from where you're
coming from near source is how you define it, as opposed
to how it's defined by the authors. And I assume that
perhaps is.
However, I also understand why is it that you put
the near source in the table, because that how it appear
in the paper probably, right?
DR. BUDROE: (Nods head.)
PANEL MEMBER ARAUJO: And the definition of the
near source is in the legend of the table. But you still
have concerns that this definition is not -- doesn't
reflect the more generally-accepted definition. So you
propose to change it to another term, and --
PANEL MEMBER HAMMOND: Yes, you have -- you
understand correctly. What I was saying maybe it could
just be near facility.
PANEL MEMBER ARAUJO: But that introduces another
problem, which is when people go and go to the original
source, or paper, so they would see what it was they were
talking about. So why they're calling this near source
versus near facility or whatever. What if, and instead,
you know, he either puts like quotation marks on the near
source, one possibility, or another possibility that he
specifies in the legend of the table near source as
J&K COURT REPORTING, LLC 916.476.3171
46
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
defined by the authors in this paper is, and then gives
the definition.
But I think that there is a value of keeping the
terminology just as it was used in the paper to facilitate
understanding of the document when people go to the
original source. What do you think?
PANEL MEMBER GLANTZ: Well, I -- this is Stan.
Well, I would -- I think that's a good suggestion, but I
would actually -- to have the document itself clearer, I
think the suggestion of saying "near facility" in the
table, and then in the footnote say in the paper this is
called "near source", so that the language in the table --
I mean, this is a point I missed when I went through it.
But I think now that it's been brought up, you can say
near facility in the table, and then just have a footnote
that says in the original paper, the language that was
used was near source. And I think that will -- that will
get at what you're saying --
PANEL MEMBER ARAUJO: Right.
PANEL MEMBER GLANTZ: -- and also fix the thing
Kathy was worried about.
PANEL MEMBER ARAUJO: I would agree, absolutely,
yes.
PANEL MEMBER HAMMOND: I agree.
CHAIRPERSON KLEINMAN: Okay. On that note.
J&K COURT REPORTING, LLC 916.476.3171
47
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
John, you can handle those kinds of changes?
DR. BUDROE: We can definitely handle those
changes.
CHAIRPERSON KLEINMAN: Okay.
PANEL MEMBER GLANTZ: So I'll move the motion
that the Chair suggested.
PANEL MEMBER BLANC: You have to restate the
motion.
PANEL MEMBER GLANTZ: Oh, I do. Okay. Well, so
I move that the Panel approved the report, subject to the
minor clarifications that have been discussed at the
meeting, and that the updated report be delivered to the
Chair for approval. And should the Chair think there's
anything substantive, he can always bring it back to the
Panel. But if the Chair finds that you've sub -- you've
correctly made the changes the Panel suggested, then the
report would be finished.
PANEL MEMBER BLANC: I'll second the motion.
Paul Blanc.
CHAIRPERSON KLEINMAN: All in favor here?
(Hands raised.)
CHAIRPERSON KLEINMAN: Everybody is unanimous.
Kathy?
PANEL MEMBER HAMMOND: Aye, yes.
Aye.
J&K COURT REPORTING, LLC 916.476.3171
48
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
CHAIRPERSON KLEINMAN: Okay. It is passed
unanimously.
PANEL MEMBER RITZ: Mr too, Beate.
CHAIRPERSON KLEINMAN: Oh, I thought I heard you
say it.
Okay. Thank you, Beate.
All right. That concludes the session on TBAc.
We are, wow, remarkably on time. And we're ready
to start a briefing on chlorpyrifos. Now, this is an item
that's going to be presented by Department of Pesticide
Regulation on the Toxic Air Contaminant Program for
Pesticides. And they'll be giving us an introduction to
their risk assessment for chlorpyrifos proposing that it
be listed as a toxic air contaminant.
By law, the health risk assessment supporting a
proposed listing of a substance as a toxic air contaminant
is to be reviewed by the SRP.
So as a background, Division of Pesticide
Research published a draft risk assessment in December of
2015, and received several comments from stakeholders
after a public review. In August of 2017, DPR published a
second draft, made it available for public comments which
closed on October 2nd of 2017. DPR staff has since
revised the document in response to those comments. And
those comments were sent to this Panel a few days ago for
J&K COURT REPORTING, LLC 916.476.3171
49
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
the initiation of our peer review.
By law, the Panel must review the scientific data
on which the report is based, the scientific procedures,
and methods used to support the data, and the conclusions
and assessments on which the report is based.
If the Panel finds that the report is not
sufficiently deficient, we must submit written findings to
the DPR Director, who decides if a pesticide should be
listed as a toxic air contaminant. So if the Panel finds
a report is deficient, then we will advise the Director
for accordingly.
Because the document was sent to the Panel too
soon before the date of this meeting, and also it has been
a long term before -- since the Panel considered a
proposed toxic air contaminant, we've asked DPR staff to
provide us with a background briefing on the chemical, and
an overview of the DPR report, and a description of some
charge questions that DPR is specifically asking the Panel
to address.
The DPR chlorpyrifos report -- chlorpyrifos --
sorry -- report dated December 11th, 2017 has been sent to
the Panel. It has been posted on the DPR website, and
that has been noted on the public notice for this meeting.
Let me also take note that the Panel received
written comments in a letter dated December 4th from
J&K COURT REPORTING, LLC 916.476.3171
50
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
Californians for Pesticide Reform, and attached to their
letter, they also included a copy of their technical
comments dated October 2nd, 2017 submitted to DPR on the
August 2017 chlorpyrifos public review draft.
They also sent a copy of comments from Health
Professionals submitted to the U.S. EPA supporting U.S.
EPA's 2016 revised human health risk assessment for
chlorpyrifos, and also a copy of a letter dated October
2nd, 2017 to the DPR Director from 84 organizations
calling for greater protections from chlorpyrifos for
California's children.
The Panel is going to review those comments as
part of its review of the report. So with that, I'd like
to turn the meeting over to Marylou Verder-Carlos who is
the Assistant Director of DPR who will begin the
presentation.
PANEL MEMBER GLANTZ: Can I just say one thing?
CHAIRPERSON KLEINMAN: Oh, sorry. Yes, Stan.
PANEL MEMBER GLANTZ: So I'd just like to make a
couple process comments. On the report that we just
finished, which we all thought was pretty good. It took a
year. And I think the law says it's supposed to come --
after this Panel has considered a report, it's supposed to
come back to us in something like 60 or 90 days. And, you
know, I realize these things are complicated, and
J&K COURT REPORTING, LLC 916.476.3171
51
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
sometimes it takes a little longer, but -- I'm not talking
about the DPR, I'm talking about the previous report.
But I think a year is ridiculous. And I think
that, you know, you need to come -- at least come close
to -- I'm talking to -- hi, John. I'm just complaining
that, you know, the previous report took a year to come
back to us. And I think the law says it's supposed to be
60 or 90 days.
So I think that, you know, you need to make a
effort to at least come close to that. So I don't know if
you want to say thinking about how mean I am, but...
(Laughter.)
PANEL MEMBER GLANTZ: And then I'll talk about
DPR.
(Laughter.)
PANEL MEMBER GLANTZ: Yeah. Did you want to say
anything or -- I'm -- or I just want to put that on the
record. You don't have to respond. But if you want to,
I'd love for you to do it.
DR. BUDROE: I would say that because of the
technical complexity of the document that this was a
special case, and we don't envision this happening in the
future. It was also partly meeting scheduling also.
PANEL MEMBER GLANTZ: Okay. But even so, I think
that the -- you know, the changes that were made to the
J&K COURT REPORTING, LLC 916.476.3171
52
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
working part of the document near the end, which actually
led to the risk assessment were not gigan -- I mean, there
were some substantial changes there that did affect the
risk estimates, but, I mean, most of the changes were the
background material that was added.
And I just think, you know, a year is like way
longer than 60 to 90 days. And we have had, in the past,
a few things. And I'm not saying this has happened in
this case. But there have been a couple of reports that
are basically getting sat on for political reasons. And
I'm not saying that happened here, but I do think that the
agency needs to -- if you're not going to at least come
close to what the requirements in the law, at least there
should have been some kind of justification for that.
And I think that's very important moving forward
to get back to where we're -- I mean, I think that the
timetable written into the law is one of the good things
about the law. And I think that the -- that the agency
needs to -- you know, if you can't meet them exactly, to
not have it take a year.
That -- I mean, I don't want to hijack the whole
meeting for that, but I was troubled by that.
DR. BUDROE: Okay. We will definitely endeavor
to have a faster turn around on documents that the Panel
wants.
J&K COURT REPORTING, LLC 916.476.3171
53
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
PANEL MEMBER GLANTZ: Yeah, and again, the law
has a specific requirement in it. It isn't like me making
that up, so we should -- so anyway.
And with regard to DPR, I have to say having this
huge report dumped on us two days -- or a day or two
before the meeting and all the -- and I would say this to
the public commenters, too, that, you know, I understand
that this is -- we're just being briefed to help us get
going into the document, but it would have been nice to
have gotten it a week or two in advance, especially given
the length and complexity of it, and the fact that this is
going to be controversial. To at least have had a chance
to look at the document, and look at the public -- not
study them, you know, but to at least look through them to
come to this meeting with some idea of what questions we
had. It would have made this a much more effective
briefing.
I mean, it's like when I tell my students in my
statistics class, try doing the problems before I lecture
on them. You don't have to do the problems. You don't
have to turn your homework in. But if you try them a
little bit, you'll come in with a lot sharper questions in
your mind and you'll get a lot more out of the lectures.
And, you know, I think that's the case here. I
mean, I actually did make an attempt, but it's just
J&K COURT REPORTING, LLC 916.476.3171
54
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
impossible you know. I mean, I got to read -- I read your
charge. I opened the document and saw that it was very
thick after I printed it out. And I spent a -- I like
looked at the public comments, which is what I usually
start with when I do this, enough to see that there were
some -- there was a broad spectrum of opinions being
represented there.
But if I had had a week, or better yet two weeks,
to do that, even though I wouldn't have been coming in
here with detailed comments on anything, this briefing
would have been way more useful. And I just never want to
get a pile of stuff dumped on me a day or two before the
meeting, you know.
And, I mean, the public commenters do that too
sometimes, which I think is not in their interest,
because -- because this -- these reports are highly
technical, and difficult in many cases. And having the
time to be able to go through what everybody says
carefully and think about it a little bit before we come
in here is, I think, one reason this process has worked so
well.
And we just -- and I think if there's someway to
tell the public that they -- you know, if they -- that
they can't depend on us to read anything they send in two
days before the meeting. I mean, it's a joke.
J&K COURT REPORTING, LLC 916.476.3171
55
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
So I hope this never happens again on this report
or anything else.
CHAIRPERSON KLEINMAN: Well, I'll take partial
blame for having the report delivered at the last minute.
And my rationale was that we had gotten access to the
early draft, which went out for public comment. And the
public comments were quite extensive and did require a lot
of rewrite.
And I felt that since we -- you know, the public
draft had been available, and we had some idea of what the
comments were, I thought it would be useful, even though
we were not going to review it today, for us to get this
preliminary presentation on it.
So the intent is not to --
PANEL MEMBER GLANTZ: No, I -- I agree that the
preliminary presentation is a good idea. I think it's
going to be very helpful in going through the document and
the public comments and, you know, thinking about it.
But what I'm objecting to is that, you know, I
mean, if you're going to send us all this stuff, send it
to us with enough time to at least look at it, you know,
without trying to do it at midnight the night before. I
mean, it's just there -- to me, I mean, it's just like --
and I don't want to go on and on.
I mean, I just got in a huge argument with the
J&K COURT REPORTING, LLC 916.476.3171
56
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
FDA about this on a different issue. But the -- but you
know, it's like students turning in, you know, term
papers. You know, if you push -- if you guys had just
maybe worked all night or a couple of weekends a couple
weeks ago, you could have gotten us this stuff in enough
time to at least look at. I'm not saying study it.
But, you know, if you're going to send it to us
before we had this meeting today, which I think in
principal was a good idea, I think it was a very good
idea, but you know, we should have gotten it in enough
time to let people look at it, given that this is not the
only thing we do in our lives.
CHAIRPERSON KLEINMAN: Yeah. Originally, it
might not --
PANEL MEMBER GLANTZ: I'll stop beating that, but
I was --
CHAIRPERSON KLEINMAN: Yeah. Originally, my
thought was just to prevent that kind of, you know,
negative reaction just to send the executive summary,
which was only 13 pages and then --
PANEL MEMBER GLANTZ: Well, even that -- and I
didn't want to take too much time --
CHAIRPERSON KLEINMAN: But, yeah, I agree that we
won't --
PANEL MEMBER GLANTZ: But even that, given
J&K COURT REPORTING, LLC 916.476.3171
57
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
everything else I've been having to do and all the other
deadlines I've had to meet because of my day job, you
know, it just -- even to read a -- because I tried to read
the executive summary like at 11:30 at night when I was
exhausted. And it's just -- it does not serve the process
well.
And I think if somebody has got to stay up all
night on this, it should be you guys, to get us in enough
time that we can, you know -- I mean, I think this would
have been a much more useful meeting had I had the time to
read the executive summary when I was awake.
And I just think you need to -- I mean, you need
to just -- this has been cooking for a long time. And
you've been working on it for a long time. And having,
you know, doing whatever you need to do to get us just --
even just a week before the meeting. And it would have
been better to have been two weeks, you know, so we could
have not come in here with this huge pile of stuff sitting
on my dining room table making me feel guilty.
So I don't really want to be ever put in that
position again as a member of this panel. I just -- and
again, the same thing holds for the public, because we
have had substantive -- not on this necessarily, although
to some extent on this.
But we've had other documents come through where
J&K COURT REPORTING, LLC 916.476.3171
58
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
we get lengthy public comments coming in at the last
minute, and OEHHA has actually managed to have responses
to them at the meeting. But it's way better to have not
only the comments, but OEHHA's responses before the
meeting so we can -- at least for me personally, so I can
read it and I think about it before I come in here. But
then you can't get in a position of jamming OEHHA either.
So I think there needs to be some, you know, real
discipline imposed on this process if it's going to work
well.
So I'll stop having -- I mean, but I got real --
I mean, because I try to take this very seriously. And I
feel really bad that I got all this stuff sent to me and I
didn't get a chance to even skim it.
CHAIRPERSON KLEINMAN: Well, I agree that this
has not been optimal, but we will have the chance to go
into this in-depth next month. But for now, I'd like to
turn this over to Marylou to give us the briefing.
Thank you.
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Good
morning. I would like -- first of all, I'd like to
introduce our team that worked on chlorpyrifos. While
Randy and I are going to be doing the presentation, the
team -- our team in DPR is composed of Shelley DuTeaux,
our Branch Chief for Human Health Assessment -- Dr.
J&K COURT REPORTING, LLC 916.476.3171
59
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
Shelley DuTeaux. Dr. Svetlana Koshlukova, our Risk
Assessor Supervisor; and then Terry Barry, who is our
exposure assessor; and Erik Kwok, the supervisor of the
Exposure Assessment Branch -- Exposure Assessment Section;
Marilyn Silva, who was the main risk assessor for this
chemical; and also Carolyn Lewis, who worked on this. So
we worked on this for, like you said, a long time.
So Dr. Glantz, we're -- we apologize that this
was only two days before. But like Dr. Kleinman said, we
would really like to have an in-depth discussion on this
next month.
So anyway for -- then Randy Segawa, a special
advisor for the Director, who is going to start the
presentation. And then I'm going to take over in the --
during the risk assessment part.
(Thereupon an overhead presentation was
Presented as follows.)
DPR SPECIAL ADVISORY SEGAWA: Good morning. I am
Randy Segawa, Special Advisor the DPR. And since it's
been awhile since this Panel has reviewed a pesticide, and
a number of you are new, we thought that we'd go over some
background information first.
--o0o--
DPR SPECIAL ADVISOR SEGAWA: Some background
information pesticide regulation in general, as well as
J&K COURT REPORTING, LLC 916.476.3171
60
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
the toxic air contaminant requirements for pesticides, and
then move on to a brief description of chlorpyrifos.
--o0o--
DPR SPECIAL ADVISOR SEGAWA: So to begin with,
under the Federal Insecticide, Fungicide, and Rodenticide
Act, what we call FIFRA, and some other federal and State
laws, three agencies within California are responsible for
the sales and use of pesticides. Those three agencies are
the U.S. Environmental Protection Agency, the Department
of Pesticide Regulation, which is part of CalEPA. DPR is
composed of six program branches, and we have about 400
employees.
And then the third agency are the county
agricultural commissioners.
--o0o--
DPR SPECIAL ADVISOR SEGAWA: DPR has extensive
programs to review, evaluate, and mitigate pesticides.
We, of course, register pesticides and we develop
mitigation measures. We have a similar process as U.S.
EPA. In fact, the process starts with EPA registration.
EPA reviews the -- any new pesticide first and makes a
decision to register. If they do register it, then it
does come to California. If there are no adverse impacts
identified or those adverse impacts can be mitigated, then
DPR would register the pesticides.
J&K COURT REPORTING, LLC 916.476.3171
61
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
After registration, DPR has a continuous
evaluation program, in which we catalog and evaluate
pesticide illnesses. We do monitoring for our human
exposure, particularly for workers. We do air monitoring.
We do water monitoring, and we monitor residues in food.
We have an extensive enforcement program in
conjunction with the county agricultural commissioners,
and so we evaluate use and violations as those occur, and
DPR does receive new studies from pesticide registrants or
from others that we look at. As part of the continuous
evaluation, we do have a health risk assessment program,
where we prioritize and evaluate pesticides for toxicity
and for exposure.
If we find that the risks are unacceptable, then
DPR would undertake development of mitigation measures.
That starts with DPR issuing a risk management directive.
This document specifies the scope and the goals for the
development of mitigation measures. What exposure
scenarios need to be mitigated, and gives us some target
levels to achieve.
And then we, of course, would develop those
mitigation measures, not only for potential health risks,
but potential environmental risks if needed.
DPR also has legal authority to request
additional informational from pesticide registrants, if we
J&K COURT REPORTING, LLC 916.476.3171
62
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
find that there is a potential problem and we can evaluate
that data and incorporate it into our -- both or risk
assessments as well as our risk mitigations.
--o0o--
DPR SPECIAL ADVISOR SEGAWA: In terms of use
requirements, EPA, DPR, and county ag commissioners
implement and enforce mitigation measures through use
requirements.
And there are three types of use requirements.
EPA specifies requirements through product labels. DPR
has some statewide regulations regarding the use of
pesticides, and then county ag commissioners for a certain
set of, what we call, restricted materials can implement
some more restrictive requirements as well.
And so DPR can designate some pesticides,
including chlorpyrifos, as restricted materials. And
these restricted materials have their own set of
requirements. The applications need to be made or
supervised by a certified applicator. A permit is
required from the county ag commissioners before a person
can purchase or use restricted material. And the county
ag commissioner is required to evaluate specific
applications sites and dates, then approve, deny, or
condition a permit depending on that evaluation.
--o0o--
J&K COURT REPORTING, LLC 916.476.3171
63
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
DPR SPECIAL ADVISOR SEGAWA: As I mentioned
before, DPR is part of CalEPA divided into six program
branches that you see sort of in the middle there. We
have our Registration Branch, or Human Health Assessment
Branch, Worker Health and Safety, Pesticide Enforcement,
Pest Management and Licensing and Environmental
Monitoring.
Brian Leahy is our Director, but the five people
you see highlighted there, they will be your main contacts
for toxic air contaminants led by our Assistant Director,
Dr. Marylou Verder-Carlos. And then the risk assessment
themselves are authored by the Human Health Assessment
Branch, led by Shelley DuTeaux, And Svetlana Koshlukova,
and Eric Kwok.
--o0o--
DPR SPECIAL ADVISOR SEGAWA: So moving on to
toxic air contaminant requirements. OEHHA and ARB have
their own set of requirements under Health and Safety
Code. And then DPR has a separate set of similar
requirements under the Food and Agricultural Code.
And under Food and Ag Code, Air Resources Board
is required to monitor for pesticides in air at DPR's
request. DPR is required to assess the human health risks
from pesticides in air. We have some companion
regulations that specify the criteria for designating a
J&K COURT REPORTING, LLC 916.476.3171
64
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
pesticide as a toxic air contaminant, and then DPR is
required to mitigate health risks from pesticides in the
air as needed.
--o0o--
DPR SPECIAL ADVISOR SEGAWA: So first element of
the TAC program is monitoring. This is primarily done by
the Air Resources Board, but DPR also conducts some air
monitoring. In general, there are two types of air
monitoring, that's conducted. One, that we call
application site monitoring. This is in the immediate
vicinity of a field to estimate acute short-term
exposures.
Then we also conduct ambient air monitoring.
This occurs in communities or regions of high use during
periods of high use to estimate seasonal or longer term
exposures.
Then more recently, sort of separate from our TAC
program, DPR now has, what we refer to, as an air
monitoring network that was initiated in 2011. When we
started in 2011, we were monitoring three communities
statewide for 31 different pesticides and their breakdown
products.
Beginning in 2017, we're in the process of
expanding that air monitoring network. For this year, it
currently includes four communities, then beginning in
J&K COURT REPORTING, LLC 916.476.3171
65
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
2018 we'll expand it to eight. And that monitoring does
include monitoring for chlorpyrifos.
--o0o--
DPR SPECIAL ADVISOR SEGAWA: Second element to
our TAC program is risk assessment. Under State law, the
risk assessment must include evaluation of certain issues,
including the potency of the chemical, mode of action,
levels that could cause adverse affects. Then in
addition, State law requires OEHHA to provide its funding
to the SRP for its consideration as well.
State law requires DPR's risk assessment to
undergo review by OEHHA, as well as the Air Resources
Board. In addition, DPR must release the draft risk
assessment to the public. And then, of course, the
Scientific Review Panel must also review the assessment to
determine if it's seriously deficient based on the data,
procedures, and methods used in the report, and the
conclusions. And then after these reviews, DPR does
finalize the risk assessment and moves on to risk
mitigation.
--o0o--
DPR SPECIAL ADVISOR SEGAWA: If you haven't read
the Food and Ag Code and you probably should at least --
your portions that you're responsible, this is an excerpt
out of State law, particularly as it pertains to the SRP.
J&K COURT REPORTING, LLC 916.476.3171
66
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
And so it does layout the requirements of the
issues that you need to review. Dr. Glantz also lays out
the timeline that we're responsible for as well, both the
Panel, as well as for DPR. And probably the key legal
requirement is there in subsection (c), where the
Scientific Review Panel determines that the health effects
report, whether or not it is seriously deficient. That's
the key finding that you need to make.
--o0o--
DPR SPECIAL ADVISOR SEGAWA: After the review, is
complete, then DPR's Director determines whether or not to
designate a pesticide as a toxic air contaminant. We have
the criteria in State regulations. And for non-cancer
effects, that criteria has a threshold level that is 10
times below the air concentration determined by the
Director to be protective of human health, which is a
little bit confusing. It's probably best to give you an
example. We completed a risk assessment for chloropicrin
back in 2010.
That risk assessment included a reference
concentration of 4.4 parts per billion. And so DPR listed
chloropicrin as a toxic air contaminant, because air
concentrations that were monitored and modeled indicated
that concentrations exceeded 0.44 parts per billion. And
those pesticides that have cancer effects, there's also a
J&K COURT REPORTING, LLC 916.476.3171
67
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
similar criteria for those.
--o0o--
DPR SPECIAL ADVISOR SEGAWA: DPR designates a
pesticide as a toxic air contaminant using a formal
rulemaking process, the process that is standard for the
State of California. We also list federal hazardous air
pollutants as toxic air contaminants as well. The
flowchart there shows the -- can be lengthy process for
doing rulemaking.
In the case of listing a pesticide as a TAC, it's
somewhat more of an abbreviated process. There is a
public hearing though. There's a public comment period.
And, of course, DPR needs to respond to all the comments
in writing. And so the process can take several months
from beginning to end.
--o0o--
DPR SPECIAL ADVISOR SEGAWA: Once a pesticide is
designated as a toxic air contaminant, then DPR must
determine the need for and the appropriate degree of
mitigation.
If mitigation measures are needed, then DPR would
issue a risk management directive that does contain the
regulatory target levels the air concentrations that we
want to try to achieve. State law requires DPR to develop
those mitigation measures within two years, or we need to
J&K COURT REPORTING, LLC 916.476.3171
68
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
submit a report to legislature explaining why we weren't
able to meet the two-year deadline.
And State law requires DPR to consult with
specified agencies in developing the mitigation measures,
including OEHHA, Air Resources Board, county ag
commissioners, and some other agencies.
--o0o--
DPR SPECIAL ADVISOR SEGAWA: Currently, DPR has
listed eight pesticides as being toxic air contaminants
that went through the evaluation process. Those eight
pesticides are listed there on the slide. In addition, we
have listed 38 other pesticides, because they are
designated as hazardous air pollutants under the federal
Clean Air Act.
--o0o--
DPR SPECIAL ADVISOR SEGAWA: Any questions about
what DPR does in general?
No. Okay. Moving on then to chlorpyrifos.
--o0o--
DPR SPECIAL ADVISOR SEGAWA: To give you some
background information before we actually start discussion
of the risk assessment. Chlorpyrifos is an
organophosphate insecticide primarily used on agricultural
crops. In the table there, you can see the annual use in
California since 2013. Use on agricultural crops
J&K COURT REPORTING, LLC 916.476.3171
69
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
comprises more than 99 percent of the uses. And so other
uses could be things like golf courses, cemeteries, things
like that, but the bulk of the use is for agricultural
crops.
Dow AgroSciences is the registrant for the most
highly used products, and you'll see some comments and
responses from them as well.
--o0o--
DPR SPECIAL ADVISOR SEGAWA: In the table, you
can see that for the last few years, use has been
declining. In fact, if you go back further to like the
early 2000s or so, use of chlorpyrifos was in the
neighborhood of two million pounds per year. And so since
that time use has decreased significantly.
--o0o--
DPR SPECIAL ADVISOR SEGAWA: Chlorpyrifos is used
on more than 60 crops. It is one of the more commonly
used pesticides in California. But there are a handful of
crops that do account for most of the use. Almonds,
alfalfa, orange and other citrus crops, walnuts, cotton,
and grapes comprise the majority of the use.
--o0o--
DPR SPECIAL ADVISOR SEGAWA: In terms of
application methods, a little over a quarter of the
applications are done by aircraft, both fixed wing
J&K COURT REPORTING, LLC 916.476.3171
70
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
aircraft as well as helicopter. But most of the
applications are by ground, usually either with a
ground-rig, a ground boom sprayer or airblast sprayer.
And if you're not familiar with airblast sprayer and that
term, this is equipment used primarily for orchards and
vineyards to spray the foliage.
And, of course, some of those orchards can be
pretty tall, and so these airblast sprayer spray the
chlorpyrifos, so it reaches the tops of the trees.
You might be interested as to what the breakdown
is between the more specific application methods. And
unfortunately, our Pesticide Use Reporting System doesn't
give us the specific methods. It only gives us whether it
was an air method, ground, or other.
--o0o--
DPR SPECIAL ADVISOR SEGAWA: In terms of where
chlorpyrifos is used, it's primarily used in the Central
Valley, as well as central coast and Imperial County
regions. In the Central Valley, most use would be for
almonds, walnuts, alfalfa, cotton, and grapes. In the
central coast, it's actually primarily used for broccoli
and other cold crops. Down in Imperial county, it's
primarily alfalfa and cotton.
--o0o--
DPR SPECIAL ADVISOR SEGAWA: There are currently
J&K COURT REPORTING, LLC 916.476.3171
71
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
some use restrictions to reduce the exposure to
bystanders. Chlorpyrifos is a restricted material, and so
it does require a permit from county ag commissioners. In
addition, there are label requirements to address
bystander exposures. And so between the EPA labels, and
the county ag commissioner permit conditions, there are
restrictions on how chlorpyrifos can be applied. In
addition, there are some setback distances. Minimum
distances between the sensitive sites and application.
That distance varies with the method of application, and
the rate of application.
And so for aircraft, depending upon the
application rate, the distance -- the setback distance is
between 250 to 500 feet.
For sprinkler and ground-rig applications, the
distance is 150 to 400 feet. And for airblast sprayers,
the distance is 150 to 500 feet.
--o0o--
DPR SPECIAL ADVISOR SEGAWA: And that's sort of
it in terms of the uses and background information for
chlorpyrifos.
Questions about that?
Okay. Moving then -- on then to the risk
assessment then.
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Okay. So
J&K COURT REPORTING, LLC 916.476.3171
72
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
we -- I just wanted to give you a short history of how we
have -- chlorpyrifos has been assessed on the risk
assessment side, since 1992 between EPA and DPR up to the
present.
So in '92 and '93, DPR did a risk assessment on
dietary, and occupational and indoor assessment. In 2006,
U.S. EPA had issued a risk assessment, a final one and had
a reregistration eligibility document that implemented
mitigation measures and required setbacks and other label
changes to protect bystanders, workers, and the
environment.
And then in 2011, they also had a preliminary
assessment, again after 2006. And in 2014, they had
another revised risk assessment. In 2015, DPR issued our
first draft risk assessment based on the 2014 risk
assessment as well. And also at the same time, we
designated chlorpyrifos as a restricted material in July
of 2015.
We also then issued recommended permit
conditions, like Randy said, to all county ag
commissioners with more stringent requirements on the
labels than the EPA labels that were out. In 2016, EPA
issued one issue paper in April of 2016, and then a
revised risk assessment in November of 2016.
In early 2016, they also then proposed to revoke
J&K COURT REPORTING, LLC 916.476.3171
73
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
all tolerances -- food tolerances for chlorpyrifos, but
then in March of 2017 of this year, they withdrew that
proposal. And then for DPR in -- we issued a second draft
risk assessment in August and then this one that you
received a couple of days ago.
--o0o--
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Based on
the August 2017 risk assessment, we also then based -- we
also added more restrictions for the use of chlorpyrifos
that was effective in October of this year as well.
--o0o--
DPR ASSISTANT DIRECTOR VERDER-CARLOS: So the
scope of the --
PANEL MEMBER GLANTZ: Could I -- could I just ask
a question --
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Sure.
PANEL MEMBER GLANTZ: -- because I remember
reading about the EPA putting forward this proposal and
then revoking it when the new administration came in.
And, I mean, historically, California, at least
for all the things I've been aware of from being on this
Panel, has usually been stricter than the federal EPA.
So given that the federal EP -- and usually about
10 years ahead of them in their thinking too, I have to
add.
J&K COURT REPORTING, LLC 916.476.3171
74
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
(Laughter.)
PANEL MEMBER GLANTZ: So given that we had a
situation where, you know, up until this March, the EPA
was talking about simply revoking the food uses of these
things, I mean, is that -- it just seemed again, based on
my extremely cursory review of this, that you're not
proposing to go as far as they were, is that true?
DPR ASSISTANT DIRECTOR VERDER-CARLOS: That is
true. We -- I mean, based on the risk assessment, because
we based our risk assessment in like -- on the 2014 risk
assessment of EPA, the -- although we did review the 2016
documents, we did not base our endpoints on that -- on
those documents.
PANEL MEMBER GLANTZ: Well, so one thing -- and
again, this would have been nice to have had a little more
time to think about this, but I mean one question I'm
going to have is like what was wrong with what the EPA did
in 2016, and why are you not using it?
Because again, my -- and we've, in the past, had
like joint workshops with the U.S. EPA on organophosphate
pesticides. I remember one of them was held at UCSF. And
you know, I walked out of all of those thinking that the
California their thinking was much better, and more
scientifically sound and less politicized than the U.S.
EPA.
J&K COURT REPORTING, LLC 916.476.3171
75
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
And so, you know, I think just so you're ready
for the meeting, I mean, I'm going to want to know what's
wrong with what the EPA did? And frankly, having the
Trump EPA throw the report out is almost an endorsement of
the early report.
(Laughter.)
PANEL MEMBER GLANTZ: You know, so I think that's
going to be a very serious question that's going to need
to be addressed here. And, you know, if -- I don't know
if you've -- how much you've addressed it in the pile of
stuff we got, but it better -- if it isn't really
thoroughly justified in there now, I would strongly urge
you to like do that tomorrow, and get it to us in enough
time to read it and think about it, so that we can keep
this process moving forward.
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Thank you.
And we will -- we have a more robust discussion about this
hopefully in January, and when you have already read all
the documents, but we did try to address that issue in our
document.
PANEL MEMBER GLANTZ: Okay.
--o0o--
DPR ASSISTANT DIRECTOR VERDER-CARLOS: So the
scope of the risk assessment is on non-dietary short-term
exposures, and also the acute exposure on the dietary
J&K COURT REPORTING, LLC 916.476.3171
76
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
side. And also, we did aggregate exposure, and only
bystander exposures. And really for bystander it includes
people around the site of application, who can be exposed
to spray associated with the application. And it may
include farm workers around that area and their families.
The handlers however are not included in this
risk assessment. Chlorpyrifos is a very, very big
database. And so, because, as a TAC also, we address
bystander exposures and that's why this one is what we're
addressing at this point.
Next slide.
--o0o--
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Oh. So at
this point --
PANEL MEMBER HAMMOND: Excuse -- excuse -- excuse
me. This is Kathy Hammond.
May I ask a quick question?
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Sure.
PANEL MEMBER HAMMOND: Yeah. So you're saying
why -- clearly, there must be a reason. I did not
understand why you're saying the applicators are -- risks
are not being -- and exposures are not bing addressed.
DPR ASSISTANT DIRECTOR VERDER-CARLOS: You mean
the handlers, right, mixer, loaders, and applicators.
PANEL MEMBER HAMMOND: Yes.
J&K COURT REPORTING, LLC 916.476.3171
77
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Well, for
the TAC process, the bystanders is the risk that we are
identifying. That's how we are going to assess the risk
for bystanders. That's the TAC process for us.
PANEL MEMBER HAMMOND: Okay.
DPR ASSISTANT DIRECTOR VERDER-CARLOS: And we
will be addressing the handlers once we get -- after we
finish the bystander exposures.
PANEL MEMBER HAMMOND: Okay. So you will be
doing it eventually?
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Yes.
PANEL MEMBER HAMMOND: Thank you.
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Oh, yes.
PANEL MEMBER BLANC: But not as part of this
document?
DPR ASSISTANT DIRECTOR VERDER-CARLOS: No. Yeah.
PANEL MEMBER BLANC: And can we expect that there
will be adequate air sampling data in your document, as
this has been a continual -- continuing limitation in many
of the pesticide-related documents --
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Yes.
PANEL MEMBER BLANC: -- that we have received?
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Yes. We
have air -- we have included the air monitoring, because
we've been monitoring for chlorpyrifos for a while with
J&K COURT REPORTING, LLC 916.476.3171
78
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
ARB as well. So the document would have ambient air
monitoring as well.
DPR SPECIAL ADVISOR SEGAWA: But as you'll read,
we're relying primarily on computer modeling to estimate
the exposures.
PANEL MEMBER BLANC: But are you -- are you
seeing whether your computer modeling is consistent with
the air sampling you've done in terms of validation.
DPR SPECIAL ADVISOR SEGAWA: Yes.
DPR ASSISTANT DIRECTOR VERDER-CARLOS: So, at
this time, our risk assessment reflects our most current
scientific understanding and comprehensive data review of
potential for toxicity to humans.
Next slide.
--o0o--
DPR ASSISTANT DIRECTOR VERDER-CARLOS: So for the
risk calculation summary, we calculated the risks as
margins of exposure. And for chlorpyrifos, we generally
considered target -- a target MOE of at least 100 as
health protective. And then we also calculated from
route-specific points of departure, oral, dermal, and
inhalation, and then we aggregated and combined those
MOEs.
--o0o--
DPR ASSISTANT DIRECTOR VERDER-CARLOS: So for the
J&K COURT REPORTING, LLC 916.476.3171
79
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
conclusions on the draft risk assessment conclusions to
summarize, dietary exposures are exposures from residues
in food and drinking water, and also dermal exposures
resulting from spray drift would not pose a health risk to
humans. That's the MOEs greater than 100 for children and
women of child-bearing age. And then for the -- but the
risk assessment also found that there are several
scenarios of concern --
--o0o--
DPR ASSISTANT DIRECTOR VERDER-CARLOS: -- which
include hand-to-mouth exposure in children, inhalation
exposure to children and women of child-bearing age, and
various aggregate exposures from combined media, and
lastly, exposures to aerosols in the near air application
sites, which was the driver of the MOEs that were less
than 100, so the inhalation exposure. And that's the
reason why we're taking it to the Panel for your review.
--o0o--
PANEL MEMBER GLANTZ: Just to continue reacting,
based on not having read it. But you know, the general
process that we followed in here is to worry about
sensitive subgroups. And, you know, from what I
understand from the -- from skimming through it, I mean,
the neurotoxic effects on children and fetuses are really
important.
J&K COURT REPORTING, LLC 916.476.3171
80
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
And so why are you defining the risk -- you know,
the acceptable levels when you're excluding probably the
most important subgroups, based -- again just based on
reading the newspaper and skimming through some of what
you sent already?
So that's -- I mean, that's another thing I think
you're going to need to make a really strong case for,
because if I was coming at this -- and again, I have not
had the benefit of studying the document, but I would be
saying that, you know, those are the sensitive subgroups
that you should be using to base the risk assessment on,
you know, and making sure that the exposure -- acceptable
exposure levels are set, so that you have at least 100
marginal exposure for these particular people. I mean, am
I missing something?
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Well,
so --
PANEL MEMBER GLANTZ: Based on being totally
uninformed.
(Laughter.)
DPR ASSISTANT DIRECTOR VERDER-CARLOS: You always
have a caveat to say that.
PANEL MEMBER GLANTZ: Yeah. Well, I don't want
to make it sound like -- but, I mean, again, you've -- and
I appreciate that you're coming in here to help us get
J&K COURT REPORTING, LLC 916.476.3171
81
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
into this, because it is going to be complicated. But
these are just sort of obvious questions that come up.
And I'd rather put them -- you know, pose them now and
give you guys a chance to think about it, and maybe come
up, you know, either with a clear justification, if it's
not already in the document, or come back and say we're
going to change the document. And that would save one
iteration through this whole process.
So you don't have to answer it right now --
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Okay.
PANEL MEMBER GLANTZ: -- if you don't want to.
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Okay.
Well --
PANEL MEMBER GLANTZ: But if you want to, that
would be fine too.
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Yeah.
PANEL MEMBER GLANTZ: But I'm just -- you know,
you -- I'm trying to help move things forward more
quickly.
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Right. So
the risk assessment addresses actually children 1 to 2
years old, because they're the most vulnerable based on
the risk assessment and also women of child-bearing age.
So the neurodevelopmental effects -- well, I'm going to
get to it on the next slide, is the -- is that the --
J&K COURT REPORTING, LLC 916.476.3171
82
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
--o0o--
DPR ASSISTANT DIRECTOR VERDER-CARLOS: We
addressed it with an uncertainty factor. And actually, we
would really like the Panel to address that based on the
charge questions that we're going to ask you. So there
are things that we are really asking for you to address.
So the charge questions -- probably the document
that you have is not the same order that we have it here,
but we wanted to categorize it, so that it's more readable
for the presentation.
So we would really like your comments on the
choice of acetylcholinesterase inhibition as a toxic
endpoint, and to consider the extensiveness of the
chlorpyrifos database, as well as the approach,
feasibility, and available database for selecting an
alternate endpoint. So we would really like your comment
on that.
And then also for the choice of uncertainty
factors that we use, because we did use the
physiologically based pharmacokinetic/pharmacodynamic
modeling. But there is also rodent data that is available
to us. The PBPK used the human data, and then -- but
there's also rodent data that we received a comment on for
us to be using. So we would like your comment on that.
And then we also did a 10x intraspecies uncertainty factor
J&K COURT REPORTING, LLC 916.476.3171
83
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
and then 10x for the neurodevelopmental effects.
And then in connection with the
neurodevelopmental effects, we would like your comment on
how we could use the human epi data to qualitatively or
quantitatively inform the dose response relationship,
because that's been -- you know, we -- we have reviewed a
lot of the literature that has epi data on the effects of
neurodevelopmental effects for chlorpyrifos.
--o0o--
DPR ASSISTANT DIRECTOR VERDER-CARLOS: And then
the rest of the charge questions. We would also like your
comment on using the 21-day steady state point of
departure values to evaluate the risk associated with
dermal, inhalation, and non-dietary oral exposure from
spray drift. Normally, for acute exposures, it's just,
you though, one and a half hour or one hour exposure.
But for our risk assessment, we would really like
to know if a 21-day is appropriate, because if it -- we
use just a one-to-one, one and a half hour exposure, it
might underestimate the risks to individuals residing in
areas of high chlorpyrifos use already.
So because acute points of departure do not, by
themselves, account for the elevated level of
cholinesterase inhibition already present in such
populations. So that's where we start off.
J&K COURT REPORTING, LLC 916.476.3171
84
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
And then for the -- our choice also of using the
agricultural dispersion model to estimate air
concentrations for fixed-wing aerial applications as a
surrogate for air concentrations for ground boom and
airblast. Since there are no data to address ground boom
and airblast applications, and we know that that's an
exposure scenario that we would really like to address, we
used the fixed wing aerial application as a surrogate for
those two exposure scenarios. So we would like your
comment on that to see if that's appropriate or not.
And then lastly, we would also like your comment
on the choice of adjusting air concentrations for
inhalable fractions, how will those adjustments be made.
Because when a spray drift cloud is comprised of aerosol
droplets of varying sizes, and we're not sure if -- so
what -- in our risk assessment, we did not quantify those
inhalable fractions and those that are not. So we would
really like your comment on how should we address that or
not. But in this assessment, we did not adjust for
inhalable fractions.
--o0o--
DPR ASSISTANT DIRECTOR VERDER-CARLOS: And then
for concluding remarks. The risk assessment evaluated
aggregate exposure through inhalation exposures because
that's the criteria for a TAC. And like we said, that is
J&K COURT REPORTING, LLC 916.476.3171
85
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
really the one that drove the risk assessment is the
inhalation risk. And we will make an in-depth
presentation on the risk assessment on January 23rd.
There's already a date for that.
And we can provide original studies to the Panel,
if you need that, but we do need affirmation of status to
be able to give you those documents, because they're
proprietary. But at the same time, we would also like to
offer that if you would like published literature studies,
if you would like us to send them to you, let us know, we
can send you a link of all the published literature that
we have reviewed, and we can send those to you, so you
don't have to print them out and -- or search for them.
So if you would like to do that, we can do that for you.
DPR SPECIAL ADVISOR SEGAWA: So I have a standard
form here that describes the handling requirements for
confidential data, if you choose to request that. And so
I need you to read this, and sign it, and return it back
to us either today or you can email it back to us at a
later date.
CHAIRPERSON KLEINMAN: Stan.
PANEL MEMBER GLANTZ: So I just had a couple of
other questions. So I -- there were a bunch of public
comments that were submitted, a couple of which seemed to
come in pretty late. And I just wanted to make sure that
J&K COURT REPORTING, LLC 916.476.3171
86
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
the -- that you guys -- that your responses to those
comments, do we have those for all of the comments that
were submitted?
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Yes.
PANEL MEMBER GLANTZ: Okay.
DPR ASSISTANT DIRECTOR VERDER-CARLOS: So there
were also comments that were submitted to this August risk
assessment that were addressed during the December draft
of 2015. So we also sent you our responses to those
comments. So all of the comments that we got, including
the December 2015, which was also Dow -- some of Dow's
comments. So we also sent you a lot of -- all those
comments.
PANEL MEMBER GLANTZ: Yeah. Okay. But
they're -- in particular, there was this one that came in
from a bunch of -- I mean, Mike mentioned a bunch of
public health groups or something. But just again looking
at the very beginning of it, it sounded like that came in
very late in the process. Are you responses to -- do you
know the ones I'm talking about? They had a green
letterhead. That -- we just got this a couple days ago,
and I didn't bring them with me.
Do you know the -- it was -- it was the one with
the like 89 organizations signed it or something. Has DPR
responded? Because I got the impression that came in
J&K COURT REPORTING, LLC 916.476.3171
87
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
very, very late. And I mean, is there a response to that?
Do you know what I'm talking about.
PANEL LIAISON BEHRMANN: Yes, Dr. Glantz. Those
were primarily comments that were submitted by those
organizations back during the -- during the -- back during
the public comment period on the DPR document, and also on
the U.S. EPA document. Those groups wanted to convey to
this Panel the fact that they had participated earlier in
the process. And they also commented that they planned --
once they see this new DPR document, that they will also
be commenting on this new revised document.
PANEL MEMBER GLANTZ: Okay. Well, so, but DPR
doesn't have -- so what's DPR's response? Is there DPR's
ease response to the earl -- see, that's the thing I got
confused about. It's like that's what I thought they
said, but like -- so has DPR responded to those earlier
comments, and is that available to us or --
PANEL LIAISON BEHRMANN: That's in the package
that you just received on Monday.
PANEL MEMBER GLANTZ: Okay. So DRP's responses
to that stuff, including the issues they raised with the
EPA report, because that's going to be material in this --
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Yes.
PANEL MEMBER GLANTZ: So we have DPR's responses
to that?
J&K COURT REPORTING, LLC 916.476.3171
88
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
PANEL LIAISON BEHRMANN: Yes.
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Yes.
PANEL MEMBER GLANTZ: Okay. And then -- and then
I would just, if -- if these other groups or anybody else
is thinking of responding to the December 2017 document,
again, I would really urge them to not wait until two days
before the meeting to submit the comments. I think they
should be submitted -- I mean, we can't control that, but
my advice to the public would be they need to get them in
quickly, so that DPR has a chance to respond to them.
Because I have to say, and I've said this many times, that
when I review these documents, I always read the executive
summary and then the public comments and the response to
comments to sort of try to see what the big issues are.
And then so I can judge how well they're being addressed.
So I think it is really important that that stuff
be to us with not only the comments, but the response --
although, you know, if these groups only deliver it two
days before the meeting, it's not fair to DPR to expect
them to have responded.
So everybody needs to do this with enough time
that we can get the comments and the responses are enough
before the next meeting to have time to read them, and
carefully consider them.
So that's a message both to the public and to the
J&K COURT REPORTING, LLC 916.476.3171
89
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
DPR. And if -- and as I said, if the public comes in at
the last -- you know two days before the meeting, you
know, then they can't complain that DPR didn't have time
to respond. But I think, at the same time, I don't want
to get DPR's responses two days before the meeting either.
So everyone will have a lot of time over the holidays.
(Laughter.)
PANEL MEMBER ANASTASIO: Can I ask a question
about the data that you're asking us if we'd like to have.
How many data are we talking about, and what is the data?
DPR SPECIAL ADVISOR SEGAWA: The original studies
on which the risk assessment is based. There is -- of
course, we relied on open literature, but much of it
relied on studies submitted by the registrants.
PANEL MEMBER ANASTASIO: Well, how many studies
are there, roughly?
DPR SPECIAL ADVISOR SEGAWA: Two or three
hundred.
PANEL MEMBER ANASTASIO: Two or three hundred.
DPR SPECIAL ADVISOR SEGAWA: There were --
PANEL MEMBER GLANTZ: There were 5,000 what?
DPR ASSISTANT DIRECTOR VERDER-CARLOS: They
narrowed it down from that.
DPR SPECIAL ADVISOR SEGAWA: They looked at
approximately 5,000 studies and included two to three
J&K COURT REPORTING, LLC 916.476.3171
90
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
hundred in the risk assessment.
PANEL MEMBER ANASTASIO: So we would be getting
copies of two to three hundred?
DPR SPECIAL ADVISOR SEGAWA: Correct.
PANEL MEMBER GLANTZ: So that's two or three
hundred --
DPR SPECIAL ADVISOR SEGAWA: If you want it.
PANEL MEMBER GLANTZ: So that's two or three
hundred proprietary studies submitted by industry, is that
what you're talking about?
DPR SPECIAL ADVISOR SEGAWA: It's a mixture.
DPR ASSISTANT DIRECTOR VERDER-CARLOS: It's the
volume.
PANEL MEMBER GLANTZ: Well, you should cover and
talk into the microphone for the reporter.
DR. DuTEAUX: Dr. Shelley DuTeaux. I'm the
Branch Chief for Human Health Assessment with DPR.
The volume of data -- unlike maybe some other
chemicals that this Panel has looked at, the volume of
data for chlorpyrifos is enormous. This chemical has been
studied since about 1971. And not only has the
registrant, Dow Elanco now Dow AgroSciences, done
extensive laboratory animal tests, there's open literature
on all the subjects that we've covered in the risk
assessment document, including exposure assessment,
J&K COURT REPORTING, LLC 916.476.3171
91
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
bystander -- bystander exposure, indoor dust exposure,
epidemiology, in vivo, in vitro, and in silico methods.
So it's a voluminous data set.
When we do a comprehensive risk assessment, we do
a systematic literature search, and then we narrow down
the articles that actually end up being informative for
the risk assessment. And we include those in our
references. And you'll see an extensive list of
references at the end of the risk assessment, as well as
additional references that are on a memo, which is
attachment number 2, which goes into much more detail
about the exposure assessment, which I think Dr. Anastasio
will be very interested in.
The volumes we're talking about are done under
contract labs, like Jackson and others. These volumes are
literally -- we call them volumes, and we're not joking,
bigger than Shogun. And we have, oh my gosh, Ann, do you
have an idea of how many we have?
God, it has to be more than 20.
So you're talking pounds of paper.
PANEL MEMBER BLANC: Yeah, but we could tell you
which study we wanted to look at.
DR. DuTEAUX: Exactly. You can tell us what
studies.
PANEL MEMBER BLANC: Yeah, so --
J&K COURT REPORTING, LLC 916.476.3171
92
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
DR. DuTEAUX: And they're all listed in the
references. And then what we were --
PANEL MEMBER BLANC: So I would suggest that
anybody who thinks it's a possibility that they might want
some -- to see a particular study, just turn in the signed
form today, and they'll have it. And then --
DR. DuTEAUX: And then the specific one.
PANEL MEMBER BLANC: -- if you decide that you
want to see a particularly pivotal, or troubling, or
intriguing study, you can ask -- we could ask for it.
DR. DuTEAUX: Exactly. Yes.
PANEL MEMBER BLANC: And it would also
probably -- I would probably encourage panel members to
ask for at least one, so that you could get a sense of
what an industry proprietary study looks like, so that you
can have empathy for the staff --
DR. DuTEAUX: Right, I know.
(Laughter.)
PANEL MEMBER BLANC: -- if nothing else.
DR. DuTEAUX: I agree, Dr. Blanc, is alluding to
the fact that the summary of these contract lab studies is
usually about 100 pages long. Then they include
individual animal data points for every single
measurement, in every dose group, every gender, and every
generation.
J&K COURT REPORTING, LLC 916.476.3171
93
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
So that's why these studies are so enormous to
look at. And the other thing that Dr. Verder-Carlos was
alluding to was a list of the open literature manuscripts.
What we'd like to do is be able to provide you a PubMed
public link, so you can see all of those in their abstract
form. And then click, as you are, because each of your
own organizations, be it UCLA or USC, has an ability to
get those full text manuscripts per your university's
designated status with your literature search, and your
libraries.
So but we'd be able to provide that
electronically, so you can at least have access as quickly
as possible.
Any other questions on the literature?
CHAIRPERSON KLEINMAN: Okay. I'd like to amplify
Dr. Blanc's suggestion. It will be a good idea to at
least get a look at one of these documents. But I think
as we read the article, we can identify specific things
that we want to question, and come back and just request
those specific items.
I've got -- you know, one of the charge questions
was referring to the uncertainty factors used. And could
you tell us a little bit more about -- not having, you
know, really read into the report yet, but are you -- for
example, 10x for the intraspecies. Now that's -- in
J&K COURT REPORTING, LLC 916.476.3171
94
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
occupation hygiene, that's sort of standard going from an
average to a more sensitive worker.
Do you think that's reasonable to go from a
healthy adult to a one-year old kid?
ASSISTANT DIRECTOR VERDER-CARLOS: Dr. DuTeaxu.
DR. DuTEAUX: Get into detail in January, if
that's --
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Yeah. SO
we were hoping to get into that in January. But Dr.
Koshlukova, would you like to address that.
DR. KOSHLUKOVA: Svetlana Koshlukova. I'm the
senior toxicologist of the risk assessment section.
So for chlorpyrifos, we used an intraspecies
uncertainty factor of 10. This is a default, and we have
extensive discussion of whether this is sufficient or not
to cover from the median to the most sensitive individual.
But at this point, we do not feel we have enough data to
quantify what the difference might be, and as such chose
to use the default.
In terms of the -- intra -- interspecies, animals
to humans, we felt that the model that we used to
establish the point of departures -- points of departure,
sufficiently -- it's for human, therefore we can reduce it
to one.
CHAIRPERSON KLEINMAN: Okay. Thank you.
J&K COURT REPORTING, LLC 916.476.3171
95
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
PANEL MEMBER BLANC: I think that's where likely
there could be the most questions. I think you'll really
have to work diligently to convince us that both parts of
that equation are sufficiently viewed with confidence to
allow that presumption. And that may be where the comment
in terms of the metabolism in children, for example, may
come into play, even though you state you have an added
10-fold uncertainty factor for neurodevelopmental -- lack
of newer developmental data.
So I bring that up, because often we've found
that we can, by a factor of three rather than 10, because
half of the equation seems to be satisfying enough. And I
think this will be an area in which we'll be looking to
comment from OEHHA in particular as well, since they deal
with this much more frequently than the Pesticide Branch.
I don't -- could I hear from OEHHA, if they're prepared --
or preparing themselves to address that for us in January?
PANEL MEMBER GLANTZ: Well, isn't this going to
be fun?
(Laughter.)
DR. SIEGEL: Hello. I'm Dr. David Siegel with
OEHHA. And we did submit our findings on the document.
And you have received those as of Monday. So we have
indicated our thoughts on that.
PANEL MEMBER GLANTZ: That's another thing I
J&K COURT REPORTING, LLC 916.476.3171
96
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
looked at. I used the "look rather than "read", but I
looked at about half of it. And it's clear that there is
some differences of opinion between OEHHA and DPR. And it
would be useful if DPR had anything to say about what
OEHHA said to know what this is before -- well, before the
meeting. And even -- I don't want to start like a --
whatever an infinite process, and, you know -- because I
think those are going to be big issues in the discussion.
And, you know, DPR gave us their report. OEHHA gave us
their reactions. It's not unusual for OEHHA to have a
slightly different view of these things than DPR does.
But it would be useful to get in advance DPR's comeback.
And even if OEHHA wanted to -- had any reactions
to what DPR said, you don't have to go through it at
really, you know, every little thing. But I think that
is -- you know, again, from what little I know, that's
going to capture a lot of the big issues in dealing with
this report.
And so I think the more of that that we can get
in time to read and think about before the meeting, rather
than having to like make stuff up on the fly or raise
issues that then come back three months later, that would
be really, really helpful.
So I'm not trying to make huge amounts of
additional work for everybody, but I -- I think those -- I
J&K COURT REPORTING, LLC 916.476.3171
97
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
just can't stress the value that I see in the public
comments and the response to comments, and sharpening, you
know -- thinking about these documents.
You know, and I mean one of the other things I
got a sense of. And I only got about halfway through a
quick read of the OEHHA document. But there are questions
about this issue of the appropriate endpoint that should
be used. And I think that's going to be -- and then also
the question of animal versus human data, because in these
things nothing is ever perfect.
So I think the more those issues can be, you
know, laid out for us. And, you know, the specific
questions, and pros and cons of these different
approaches, you know, the more we can help get that
focused and see what the controversies are, that is going
to really help move this process forward.
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Yes, we --
so what you're saying is we should be able to send our
responses to OEHHA's findings before the January 23rd
meeting. Okay.
PANEL MEMBER GLANTZ: Yeah, that would be very
helpful. And then if OEHHA -- I don't think we want to
set up an infinite loop here, but -- because I think the
issues will be pretty clear. But if DPR says something
that makes OEHHA's, you know, teeth hurt, you know, I'd be
J&K COURT REPORTING, LLC 916.476.3171
98
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
interested in what OEHHA -- I mean, part of it -- I mean,
I've been in things it's like didn't you read what we said
before? We don't need to repeat ourselves.
But if there are things that, you know, in light
of DPR's response that OEHHA thought were clear or, you
know, that that brings up some other issue, I would really
like to see that, you know, as soon as we could get it
just because that's -- I think that -- I think a lot of
the issues that are probably going to come up are going to
get highlighted there. And I think that will assist at
least me in trying to wade through all this stuff.
Is that okay? I mean, I think we're going to end
up doing that anyway, and it would better to get it done
now, than have the meeting in January, and then -- and
have you go -- I mean, is that okay?
This is what happens when I get to look at
something a little bit.
(Laughter.)
PANEL MEMBER GLANTZ: Blanc was much smarter, he
didn't even look at it.
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Yes, we
will. So we will work -- we will work on that, and then
work with OEHHA and see if we can --
PANEL MEMBER BLANC: But I think I -- since
this -- the purpose of this meeting, is I understand it,
J&K COURT REPORTING, LLC 916.476.3171
99
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
is to sort of lay groundwork. So rather than simply say,
well, we wrote our comments, which you didn't have time to
look at, could you perhaps summarize for us on this one
particular point of the correction factor inter --
intraspecies, with humans, of only 1, whether OEHHA had an
opinion on that. Well, it's within humans, right?
DPR ASSISTANT DIRECTOR VERDER-CARLOS: The inter.
You're saying interspecies. Within humans is the intra,
so this is a 10 is what -- or the 1, are you asking for
the PBPK model?
PANEL MEMBER BLANC: Yeah, I'm sorry That one,
yeah. Yeah, intraspecies model of 1, going from rats to
humans, sorry, right, essentially?
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Right.
DR. LIM: This is Lori Lim. I'm the senior
toxicologist with OEHHA.
In the DPR's document, a -- the PBPK model was
considered to be close to a human model. So because of
that, the interspecies, which is extrapolated using data
from animal to humans was considered not needed. While we
looked at the data, we -- we agree at the human data in
the model, but we did not believe that that model
represented true human. So we want to back off from it,
and say, well, you should at least apply a three-fold
factor, because standard default for animal to human
J&K COURT REPORTING, LLC 916.476.3171
100
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
extrapolation is a 10-fold.
PANEL MEMBER BLANC: So in other words, what I --
what I had anticipated, which is you accept half the
equation, but not the PK --
DR. LIM: Well, the model is a PK and PB model,
so it's hard to split it.
PANEL MEMBER BLANC: Right, and you -- and so
the -- right. But so you accept some of it, but not all
of it.
DR. LIM: We're saying that this model is half
human, if you want to look at it that way.
(Laughter.)
DR. LIM: Not true human. And we went -- in our
findings, we went into details about why it didn't --
it -- there's not enough human data, especially for the
inhalation component of the model that they weren't any
human inhalation toxicity study to support that component.
PANEL MEMBER GLANTZ: Was Kathy Hammond saying
something?
PANEL MEMBER BLANC: Inadvertently.
PANEL MEMBER HAMMOND: Oh, I'm sorry.
DR. LIM: So anyway, there's that problem with
lack of human inhalation toxicity study. And then the use
of the in vitro human plasma in liver samples that, you
know, we have some questions about that too. So we just
J&K COURT REPORTING, LLC 916.476.3171
101
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
didn't think that was -- it's the same as though a human
study was conducted, a well-conducted human study. Let's
put it that way.
PANEL MEMBER BLANC: Well, that's very helpful to
hear that stated, so that it can give us a framework from
which to look closely at that part of the document.
And so I would just prepare the Pesticide Branch
for --
DPR ASSISTANT DIRECTOR VERDER-CARLOS: To respond
to that?
PANEL MEMBER BLANC: Yes, and for the likely
eventuality that you will err on the conservative side --
the health protective side of allowing a 3-fold but not a
1-fold interspecies factor. So you should be prepared for
that, but give it your best shot.
CHAIRPERSON KLEINMAN: There -- yeah, I'm also
curious, because there are a lot of organophosphate
pesticides out there. And a lot of human exposures to
thing likes malathion, parathion, and all of that. And
none of that data gave you enough information on
acetylcholinesterase inhibition in terms of exposures that
you could draw analogies from real-world data and check
your model?
DPR ASSISTANT DIRECTOR VERDER-CARLOS:
Chlorpyrifos is the only organophosphate that has
J&K COURT REPORTING, LLC 916.476.3171
102
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
a very robust PBPK/PD model. That's the only one that
they -- that the scientists did a very robust PBPK model.
And that's what we had relied on for that interspecies of
one 1x. And to the point of the human data, they did
use -- what's this called -- fused -- infused human
tissues. And that's what they used -- the protocol is the
same as they used for organ transplant. And that's one of
the -- that was fully explained in the risk assessment and
that's why we used an uncertainty factor of 1 instead of 3
or a 10.
DR. LIM: I think you're referring to a whole
human study. And there are two studies the Nolan study
and the Kisicki study that are used to -- in the model.
These are intentional dosing of the human studies. And
yeah, they were specific on chlorpyrifos.
CHAIRPERSON KLEINMAN: Kathy or Beate, do either
of you have a comment?
PANEL MEMBER RITZ: Yeah. This is Beate. I
actually do. I'm very surprised that there's absolutely
nothing on the effect in elderly. Since I'm the author of
one of the papers that shows that it -- that chlorpyrifos
is actually associated with Parkinson's disease. So
neurodegeneration I think really needs to be looked at,
but I find nothing in here. Is that because these papers
are too new or is there another reason?
J&K COURT REPORTING, LLC 916.476.3171
103
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Dr. Ritz,
so that was an epi study, correct --
PANEL MEMBER RITZ: Oh, yes.
DPR ASSISTANT DIRECTOR VERDER-CARLOS: -- that
was reviewed. So we -- based on the risk assessment that
we did, the most susceptible population was the 1 to 2
year olds and women of child-bearing age, but we will
be -- we will take a look. We did not -- I don't think
that we looked at that specifically as an epi study, but I
will check with -- no, we did not.
DPR ASSISTANT DIRECTOR VERDER-CARLOS: So the Epi
data that we looked at was on neurodevelopment.
PANEL MEMBER RITZ: Right. So I would encourage
you to at least look for neurodegeneration, and for both
Parkinson's and Alzheimer's.
PANEL MEMBER GLANTZ: Do the DPR people know the
studies -- the specific study she's talking about or --
no. So they shook their head no. So I think it would be
helpful for Beate for you to send the references to DPR,
and -- just so they don't have to go get -- looking for
them.
PANEL MEMBER RITZ: Yes, that's easy.
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Thank you.
PANEL MEMBER RITZ: Can I send them to Jim and he
forwards them?
J&K COURT REPORTING, LLC 916.476.3171
104
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Yes. Jim
said yes.
PANEL MEMBER RITZ: Okay. Good.
PANEL MEMBER HAMMOND: Beate, are you done?
CHAIRPERSON KLEINMAN: Okay. I'd like to give
other Panel members an opportunity if they have questions
that would like to raise?
Cort.
PANEL MEMBER HAMMOND: This is Kathy.
CHAIRPERSON KLEINMAN: Oh, yes, Kathy, go ahead.
PANEL MEMBER HAMMOND: Sure. Sure. So this
is -- I noticed that you talked about the inhalation
fraction, and whether or not that was included. And I
just would like, because there's various definitions for
that, for you to remind me of what your definition of
inhalable fractions are?
CHAIRPERSON KLEINMAN: Kathy, you're fading out.
PANEL MEMBER HAMMOND: Can you hear me now?
CHAIRPERSON KLEINMAN: It's better.
PANEL MEMBER HAMMOND: Let me try something.
Okay. Let me try this.
PANEL MEMBER HAMMOND: The -- my question was
about the inhalable fraction. And I wanted to know a
little more, since you had kind of highlighted that point,
about what your definition there was.
J&K COURT REPORTING, LLC 916.476.3171
105
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
DR. DuTEAUX: Dr. Hammond, this is Shelley
DuTeaux again. In our risk assessment you'll find that we
assumed that all chlorpyrifos -- airborne chlorpyrifos was
available. So we assumed it was all inhaled, which is
unlike an FDA development drug where you look at a percent
of inhalable fraction, or as you know, criteria
pollutants, where there's a certain size fraction.
So our question to you in the charge questions is
if we change our approach of considering all airborne
chlorpyrifos as being inhalable to a fraction that would
be inhalable, then what would your suggested approach as
the Panel be for us to do? So, essentially, I think we're
ask --
PANEL MEMBER HAMMOND: I can give you -- Okay.
So I can give you an upfront kind of thing. But I wasn't
sure about your definition of inhalable. If you use the
occupational definition of inhalable, you know, that is
actually 50 percent of 100 micron particles are taken into
the respiratory tract. So I don't know if that's the
definition you're using, as opposed to some people in the
environmental world loosely use, what we call, respirable
and inhalable, which are much smaller particles. So when
you say inhalable, which definition are you using?
PANEL MEMBER GLANTZ: So the questions she was
asking I think -- you're kind of fading in and out, Kathy.
J&K COURT REPORTING, LLC 916.476.3171
106
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
I think she's said there were two different
definitions of inhalable, and which one are you using,
right, Kathy, is that the question?
PANEL MEMBER HAMMOND: Correct. Correct.
DR. DuTEAUX: Again, we haven't used one yet.
But if we do, then what is appropriate. And I think
Professor Hammond said that in the occupational health
world they use 50 percent of 100 micron particles taken
in. But then in environmental health worlds it's
respirable fraction, which would be approximately, I
guess, less than 10 microns.
CHAIRPERSON KLEINMAN: Actually, I think what
Kathy --
DR. DuTEAUX: Isn't that correct?
CHAIRPERSON KLEINMAN: Go ahead, Kathy.
PANEL MEMBER HAMMOND: Just to say upfront, you
definitely should be using out of, you know, kind of
minimum is the wrong term. But the point would be that
you should -- I think that you've probably done correctly
as is what you've done. But if you were to use any size
selection, it should be the occupational definition, not
the environmental definition of inhalable, because it's
just -- the concept of -- is the critical concept there.
And the point is that a lot of material gets into
the body. It doesn't make it to the alveoli, but it still
J&K COURT REPORTING, LLC 916.476.3171
107
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
makes it into the body and is available to cause the kind
of effects endpoints that you're looking at, even if it's
larger than the size particles that can make it to the
alveoli. But the alveoli are not the target organ in this
case. So it's really important not to go that direction.
And I understand you haven't done that yet
either. But if, for any reason, you were going to do
that, I would say make sure that you don't go that way.
And then the other question I had was do you have
any data on the size distribution of the particles.
DR. DuTEAUX: The size distribution. So the
modeling -- the monitoring data was captured for a
particular size or type of particle in the cloud. And
then the modeling actually also has a size distribution.
So when we look at the airborne concentration, the spray
drift modeling that we used, you'll be able to see that
and ask additional details about that as well.
PANEL MEMBER HAMMOND: It's really important to
know the size distribution for any of this conversation.
But as you may well know, and again I lean to favor in
what you've already done anyway. But if one was going to
go down that path to be aware of it, for instance the size
distribution changes, and as you get further away from the
source, in this case, the particles may well get smaller
with evaporation of the vehicle.
J&K COURT REPORTING, LLC 916.476.3171
108
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
You know, so it's not like what's right near the
source, if you're talking about community exposures, but
certainly is going to have an effect. So I think your
choice was a good one, but I haven't read the document in
detail. But just on the surface of what you've said so
far, I support what you've said. But if you're under a
lot of pressure, just make sure you do not go the
direction of thinking of the alveoli as the target vehicle
-- target organ.
DR. DuTEAUX: Right. And thank you for that.
Again the -- we have two different models that play here.
We have an airborne distribution model, and then we also
have a PBPK/PD model. And in the PBPK/PD model, the way
that the modeler developments wrote the code was that
there's a certain amount that, you know, of the size
fraction that might get into the deep lung. But, of
course, acetylcholinesterase effects are not in the
alveoli.
But you can see very clearly in our description
how much was assumed by the model code actually then went
up through the mucociliary pathway, was then ingested, and
was considered a whole-body dose, or site-specific dose
through that route. So the model is very specific when it
comes to that.
And then just a note on the atmospheric modeling,
J&K COURT REPORTING, LLC 916.476.3171
109
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
the -- we made some very conservative assumptions in that
modeling. And one of which is that we treated the
droplets like their water, i.e. there is no vaporization
of the size. And so the size kind -- maintains its size
in diameter far afield, and doesn't evaporate. And so
that's one thing that's also another conservative
assumption that we put in.
PANEL MEMBER HAMMOND: So I actually disagree
that that's a conservative assumption. I think that
that's an assumption that would lead to -- if you
did -- if you did do it, if you were to actually --
PANEL MEMBER BLANC: Kathy. Kathy. Kathy, Paul
Blanc here. Are you using a speaker phone?
PANEL MEMBER HAMMOND: No, I'm using a -- I've
got a plugged in headset, but I guess it's not working
well.
PANEL MEMBER BLANC: It's not working. I wonder
if you could unplug that and just use --
PANEL MEMBER HAMMOND: Oh, I'll try it. Sure.
Is this better?
CHAIRPERSON KLEINMAN: A lot.
PANEL MEMBER HAMMOND: Okay. My apologies.
PANEL MEMBER BLANC: Yes, yes.
PANEL MEMBER HAMMOND: Okay. Sorry.
Yeah, I've just got it to my ear now.
J&K COURT REPORTING, LLC 916.476.3171
110
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
Okay. What I'm saying is that rather than
calling that a conservative assumption, I think it's the
exact opposite of that. That it actually leads to an
underestimate, if you assume the particle size does not
change. Because again, if you take everything that comes
in, which is what you did, then it makes no difference, of
course, and I get that, and I support that.
But you are getting any pushback or you're trying
to look at what it would be if you took it -- made another
set of assumptions, then I would say that the -- what
you -- you do have to take into account the fact that the
particle size will change, I mean, is a pretty critical
piece of that.
And then that would make more things,
biomonitoring, available. Does that make sense? Or we
talk about that, if you want, like you know, later, off --
after this meeting or something.
DPR ASSISTANT DIRECTOR VERDER-CARLOS: In
January?
DR. DuTEAUX: In January?
PANEL MEMBER HAMMOND: I January, sure. But I
just want to -- I mean, I guess what we're trying -- I
really appreciate getting this heads up on what you all
are doing, because it helps to focus as we reviewed the
document. But I also want to give you a heads up on how
J&K COURT REPORTING, LLC 916.476.3171
111
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
I'll be looking at it.
DR. DuTEAUX: Sure. And that's why we posed it
as one of the charge questions, because we think it's very
important as well.
PANEL MEMBER HAMMOND: Sure, uh-huh.
That's why I'm taking it seriously, right, right.
Yeah.
PANEL MEMBER ANASTASIO: This is Cort Anastasio.
I want to follow up on some of Kathy's points. Shelley,
are you saying not allowing the drops to evaporate is
conservative, because you're not allowing the chlorpyrifos
to evaporate from the drops?
DR. DuTEAUX: Yes. I mean, we're treating it
like it has a vapor pressure of water --
PANEL MEMBER ANASTASIO: Right.
DR. DuTEAUX: -- instead of it's true vapor
pressure.
PANEL MEMBER ANASTASIO: And so part of that is
you're not considering any risk from gas phase
chlorpyrifos?
DR. DuTEAUX: It's vapor phase.
DR. DuTEAUX: Our modeler.
DR. BARRY: I'm Terry Barry. I'm the modeler for
the environmental concentrations. So let's back up a
little bit. So the AGDISP model is a first principles
J&K COURT REPORTING, LLC 916.476.3171
112
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
physics-based --
PANEL MEMBER GLANTZ: Can you pull it closer.
DR. BARRY: I could hear myself, so I was
thinking you could hear me.
Okay. The AGDISP model is a first principles
physics-based model, and it models droplets as an ensemble
cloud. What we assume the chlorpyrifos is it's not
volatile. So the AI itself does not disappear and go into
the vapor phase, but the droplets do get smaller. As you
go down wind, they evaporate. There's gravitational
settling. There's deposition. In fact, you can lose
material, you know, off the model domain too, if you go
far enough, because it's 2,608 feet is the reasonable
border, you know, for the model. And then you'd have to
hand it off to a gassy blue model, and then you're talking
about actual vapor size. You know, vapor -- no droplets
anymore basically, just vapor.
So the conservative part that Shelley was
pointing to is that we assume that the AI is not volatile,
so it doesn't disappear. It doesn't get smaller. It
doesn't, you know, mix vertically significantly.
PANEL MEMBER ANASTASIO: Right, but that's only
conservative because you're assuming that the gas phase
material has no toxicity.
DR. BARRY: Right. And you will get to that in
J&K COURT REPORTING, LLC 916.476.3171
113
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
the document, because EPA made a judgment call that vapor
phase is not something that they were looking at, because
you could not get 10 percent acetylcholinesterase
suppression at the saturated vapor pressure. And we
elected to go with their judgment on that, so that's why
we didn't look at vapor phase. So -- and the aerosol
phase does plenty obviously.
PANEL MEMBER ANASTASIO: But the vapor phase is
an open question potentially for the neurodevelopmental
toxicology.
DR. BARRY: Well, that's for you guys to debate,
right?
PANEL MEMBER ANASTASIO: Oh, okay.
DR. BARRY: So doe that --
PANEL MEMBER HAMMOND: Right. Does that -- So
you start with -- you have a drop of a chemical in it and
it changes size and then perhaps goes into the vapor
phase. It will only go into the vapor phase, of course,
by the, you know, the -- but other ever -- but the point
really is that you will inhale that much vapor. And you
can't say -- and I think you haven't done this, all right.
So I'm even talking about the U.S. EPA thing.
But you can't say, oh, it all goes into the vapor
phase, so we don't have to take it, so it's not in the
particles. We're only monitoring the particles. But, in
J&K COURT REPORTING, LLC 916.476.3171
114
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
fact, you've also said that it can't go into the vapor
phase that's why we can ignore it. It's kind of a little
bit of a --
DR. BARRY: We're not really ignoring it.
Oh, I'm sorry. I thought you were finished.
PANEL MEMBER HAMMOND: No, you aren't. You
aren't --
DR. BARRY: Oh, okay.
PANEL MEMBER HAMMOND: -- but I mean it sounds
like the EPA did.
DR. BARRY: So the primary drift part is the mass
that's released from the aircraft during the application.
And the AGDISP model handles that mass that's released
from the aircraft, and it distributes it according to a
droplet spectra that's produced by the nozzles on the
aircraft and how fast it's going, what kind of aircraft it
is, and things like that.
So all of the mass that is release from the
aircraft is accounted for by the model, and then it's
distributed down wind according to physics. So that's
what we're using for our primary drift inhalation
estimates. Vapor phase is going to be more related to
secondary drift, which would be off-gassing from the
application after the application is finished. And that's
what EPA was pointing to with the vapor phase not being
J&K COURT REPORTING, LLC 916.476.3171
115
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
something that they were going to look at.
The thing about the AGDISP model is the droplet
spectra goes to be extremely small. And the question
about the inhalable fraction actually is, okay, so do we
do 100 microns, do we do 150, 200 microns, 50 microns, you
know, we need to -- if we're going to adjust, we need to
decide how we're going to adjust and that droplet spectra
changes both with distance and with height.
Okay. So there's -- it's -- it's quite
complicated. So we elected so far --
PANEL MEMBER HAMMOND: Right.
DR. BARRY: So we elected so far to assume that
100 percent of the droplet cloud at a particular point,
which is going to be the inhalable height of a child or
the inhalable height of an adult at a particular distance
down wind is going into the person. And some of those
droplets are 250 microns, 350 microns. I mean, they're
big, but we've assumed they're all inhaled right now.
So the question for you guys was should we still
do that or should we look to try to really refine this
model -- this exposure to what we know about the droplet
spectra because model will give you all of the droplet
spectra at any height and any distance. It's a pain to
produce, but I could give it to you.
PANEL MEMBER ANASTASIO: Is there an example size
J&K COURT REPORTING, LLC 916.476.3171
116
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
distribution in the documents?
DR. BARRY: Yes.
PANEL MEMBER ANASTASIO: Okay.
DR. BARRY: In the appendix of the memo at the
end, I printed out the air concentrations and then it's
the per below 100 microns I think or below 10 microns, but
I can give you guys more data, if you want it. So I
characterized what would happen if you made adjustments,
you know.
CHAIRPERSON KLEINMAN: But I think it's important
to keep in mind that what you're talking about is an
aerosol.
DR. BARRY: Yes.
CHAIRPERSON KLEINMAN: And you've got these
liquid droplets, and they're really suspended in saturated
vapor. The vapor doesn't go away.
DR. BARRY: Oh, right. Right.
CHAIRPERSON KLEINMAN: So --
DR. BARRY: The model accounts for that.
CHAIRPERSON KLEINMAN: The model will capture --
DR. BARRY: Um-hmm.
CHAIRPERSON KLEINMAN: -- the amount of vapor
that's there, and so because that's going to give you a
constant background --
DR. BARRY: Right. Yeah.
J&K COURT REPORTING, LLC 916.476.3171
117
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
CHAIRPERSON KLEINMAN: -- you know, moving alond.
DR. BARRY: In fact, there has been a refinement
to AGDISP model to account for the higher humidity in the
cloud. They just -- in fact that's why we're using the
version we're using accounts for that.
And the other thing that -- you'll see it in the
memo, but the other thing about the AGDISP model is that
it's -- it's been -- it was reviewed -- it was reviewed
at -- Spray Drift Task Force workshop back in the
nineties. It's used for regulatory purposes by EPA. I
mean, this is not a, you know, sidebar model. We're using
a really well established model here for a purpose that
it's meant to be used for.
So going forward, as you look at the documents,
you know, just keep that in mind.
PANEL MEMBER ANASTASIO: I think what mike was
saying, and maybe he can clarify this, you're saying it's
saturated in chlorpyrifos not water?
CHAIRPERSON KLEINMAN: Yeah.
PANEL MEMBER ANASTASIO: Right, but you're
talking about water, saturated in water?
DR. BARRY: I'm talking about droplets with
chlorpyrifos in them.
PANEL MEMBER ANASTASIO: Okay. You're talking
about higher relative humidity in the cloud?
J&K COURT REPORTING, LLC 916.476.3171
118
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
DR. BARRY: In the cloud of droplets. And each
droplet has a certain amount of AI in it. I mean, that's
what the model is doing. Yeah, and you can get the
droplet spectra anywhere you want down wind. You can
actually get it on field too. I mean, it's -- you know,
you could get it for that too.
Well, actually, that's going to be what's
released. That's the droplet spectra of the nozzle
itself, so...
PANEL MEMBER ANASTASIO: While we're on AGDISP,
one comment about charge question number 4. You assumed a
fixed wing aircraft application, because there's no data
for the other two application methods. I don't think our
Committee has the expertise to know whether that's a good
assumption or not. So my suggestion is before the January
meeting, try to seek out people who might have that
expertise. I would think somewhere in the U.C. system
there must be people who do this, and they may be able to
help you with that question, because I'm not sure that we
have that expertise.
CHAIRPERSON KLEINMAN: Well, it looks like we're
going to have a very exciting month ahead of us --
(Laughter.)
CHAIRPERSON KLEINMAN: -- just going through
this.
J&K COURT REPORTING, LLC 916.476.3171
119
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
Does anybody else have, you know, additional
questions that we want to ask? I think we've sort of run
the gamut on this, and we'll -- you know, I think one of
the approaches that we can take now going forward is first
off to look at, you know, the charge questions, which I
guess represent some serious uncertainties that DPR has,
and look at them and, you know, see whether what's, you
know, in the report gives us enough information. If not,
come up with a wish list of what we need to be able to
answer the charge questions.
Because this is so complicated, I don't think our
normal procedures of hire -- you know, of assigning one or
two people as leads is going to be as effective as a
lot -- you know, each area touches on different people's
expertise.
And I think I would prefer, you know, after
everybody has had a chance to really look at the document
that we each carve out a section and -- you know, so for
example, obviously, the epidemiology Paul and Kathy and
Beate are probably closer to, you know, the human exposure
data, and also the occupational exposure data, you know.
And we each have our various toxicologic bents.
So if you could get back to me with, you know,
what areas you would like to take the lead on, I think I
would like to see this one done with sort of individual
J&K COURT REPORTING, LLC 916.476.3171
120
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
responsibility for, you know, things that we're good at,
rather than trying to cover the entire base, because we're
all going to read this.
This is really an interesting document. It's a
very interesting issue, and it's the first one we've had
in, I guess, more than a decade, so I'd like to see this
done really well.
On the -- now, our next meeting is scheduled for
January 23rd. And so we'll be ready to start, you know, a
really in-depth review at that point.
PANEL MEMBER RITZ: So, Mike, this is Beate. I
Actually have to un, but I'm happy to review the epi,
especially everything neurotoxic related.
CHAIRPERSON KLEINMAN: Okay. Great. Thank you,
Beate.
PANEL MEMBER RITZ: And if you need me to review
other parts, just let me know.
CHAIRPERSON KLEINMAN: Will do.
PANEL MEMBER RITZ: Okay. I will sign off
then --
CHAIRPERSON KLEINMAN: Okay.
PANEL MEMBER RITZ: -- unless you have something
else?
CHAIRPERSON KLEINMAN: No, I think we're just
about to wrap-up too.
J&K COURT REPORTING, LLC 916.476.3171
121
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
PANEL MEMBER RITZ: Okay. Thank you so much,
Mike.
CHAIRPERSON KLEINMAN: Thank you very much for
joining us.
PANEL MEMBER RITZ: Happy Holidays.
CHAIRPERSON KLEINMAN: So just from the brief
interlude here, I'm not going to, you know, make a
prediction that we'll be anywhere near done on the 23rd,
but I think we'll be able to make some really good
inroads. And I think eventually, we will be able to
schedule, you know, to get this through and done.
I do want to congratulate DPR on a very, you
know, interesting document. I think -- you know, what
I've seen of it, it looks, you know, really well done.
You've responded to a lot of public comment already. So
at least the initial work is there. It's a strong start.
And I think we will be able to make good use of it.
PANEL MEMBER GLANTZ: You know, to that end, you
know, I haven't looked at the schedule, but, I mean, I
think it would -- since I agree with you, the chances
we're going to finish this at the next meeting is pretty
small. So I really think the staff ought to schedule
several meetings now so that -- because -- you know,
because scheduling is always hard, so that we can keep
this thing moving forward at a good clip.
J&K COURT REPORTING, LLC 916.476.3171
122
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
And if we finish faster than we want or we -- not
than we want, faster than -- and we run -- and we don't
need anymore meetings, I've never met a person who
objected to a meeting being canceled.
(Laughter.)
PANEL MEMBER GLANTZ: But I think -- I think we
want to -- we don't want to wait till January 23rd and so
oh, we need to meet again, and then we end up meeting in
April, because of scheduling problems. So I mean, Jim, I
think ought to get on -- get this worked out now and for
like having -- you know, schedule like three more meetings
after that. We probably won't need them all, but to get
it on the calendar.
PANEL LIAISON BEHRMANN: Okay.
PANEL MEMBER ANASTASIO: I have one point as
well. I don't know in all the documents you gave us, if
the 2016 EPA report is among them. It would be helpful to
have access to that.
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Yeah, we
can -- we did not provide it in your packet, but we can
certainly. It's available online, so we can download it
and send it to you.
PANEL MEMBER ANASTASIO: Yeah, that would be
great. And then is the SAP report separate from that?
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Yes. Yes.
J&K COURT REPORTING, LLC 916.476.3171
123
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
PANEL MEMBER ANASTASIO: Okay. That would
be use --
DPR ASSISTANT DIRECTOR VERDER-CARLOS: The SAP
review came after their April -- the issue paper that they
came out with in April, there was an SAP review, and that
was the review that was given to them. And then the
November 2016 document was the last one that came out from
EPA on chlorpyrifos.
PANEL MEMBER ANASTASIO: Okay. I think it would
be helpful to have those last two pieces.
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Okay.
PANEL MEMBER ANASTASIO: Thank you.
CHAIRPERSON KLEINMAN: So, you know, in response
to Stan, we probably should allow a month after the next
meeting to allow DPR to respond to whatever comments. And
I suspect there will be a lot of them. So can we schedule
something like the -- let's say the week of the 12th of
February or go on to the 20th maybe would be -- the week
of the 20th.
PANEL LIAISON BEHRMANN: This is Jim Behrmann,
the panel liaison. We will poll the Panel for the -- all
of the months after February. You're going to want to
allow time for staff to revise the document, and then to
send it out and have time for you to review it.
So giving the DPR staff a month say to revise the
J&K COURT REPORTING, LLC 916.476.3171
124
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
document, we wouldn't to meet before March 23rd, but we
will -- I think that's being quite ambitious actually.
So --
PANEL MEMBER GLANTZ: Well, you know, I'm
ambitious. I mean, I think we should schedule like a
month -- a meeting every month now. And if we get
there -- I mean, we'll have to see what we demands are put
on DPR at the January meeting, and if we think that
there's not enough time for them to deal with it and get
the document back and give us enough time to read it, we
always cancel a meeting, you know.
But I think we just -- I think -- you know,
getting back to my earlier comments about the first
document that it took a year. I think, we -- you know, we
don't want to drag this process out just cause of
scheduling. And, you know, so that -- my suggestion would
be to try to have something on people's calendars every
month for the next several months, and then we could just
cancel them, if we don't need them.
But if we decide -- if decide we decide we need
it, then scheduling something that quickly for most people
is really hard, because you're talking about a whole day.
PANEL LIAISON BEHRMANN: As I said, we will poll
the Panel, and I would ask that the Panel also be, if you
can, make yourself as available as possible. We will have
J&K COURT REPORTING, LLC 916.476.3171
125
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
to probably accept the fact that we will not have meetings
with the entire Panel. It's very seldom that we're able
to get all nine members, but we will poll and strive to do
so.
DPR ASSISTANT DIRECTOR VERDER-CARLOS: Also, if
there are questions before the January 23rd, you can
please contact us, so that we can provide you with
anything that you will need to review the document.
CHAIRPERSON KLEINMAN: Yeah. I think in terms of
the logistics, we probably ought to funnel questions
through Jim, because I guess we're not allowed to really
caucus about things. And this way if it goes to Jim, he
can send things to everybody and we can all see things, so
we're not, you know, sending a lot of the same repetitious
material over.
PANEL MEMBER GLANTZ: Yeah. Although, I can say
that, you know, this is where it's good that I've been
here forever. You know, there's -- it's not -- we cannot
have a quorum to have a unnoticed meeting, but there have
been other things that I've been involved with, where
there have been meetings of one or two members with the
appropriate State staff. I mean, I've done this several
times to kind of hash things out in between the meetings,
so that we don't have to waste a lot of time of the whole
committee on some highly technical point that, you know, I
J&K COURT REPORTING, LLC 916.476.3171
126
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
or one of the other members is upset -- not upset. That's
the wrong word, but wants to -- doesn't understand or
wants to discuss.
So, I mean, there's not -- for the new --
relatively new members of the panel, I mean, if -- I think
if anybody thinks it would be useful for one or two people
to have a meeting with the DPR or OEHHA staff outside of
the regular meeting process, that is permitted.
And you can call people. You can talk to them on
the phone. You can do that. The thing we can't do is
have a quorum of the Committee all, you know,
deliberating. So, you know, I think -- I think
fundamentally -- I mean, I think keeping Jim in the loop
is a good idea, but there's no reason to overly
bureaucratize the communication either.
CHAIRPERSON KLEINMAN: Okay. Well, if there are
no other items to be brought before us, I would ask for a
movement to adjourn.
PANEL MEMBER BLANC: I move.
CHAIRPERSON KLEINMAN: Paul moves.
PANEL MEMBER ANASTASIO: Second.
CHAIRPERSON KLEINMAN: Second by Cort.
We are adjourned.
(Thereupon the California Air Resources Board,
Scientific Review Panel adjourned at 1:28 p.m.)
J&K COURT REPORTING, LLC 916.476.3171
127
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
C E R T I F I C A T E O F R E P O R T E R
I, JAMES F. PETERS, a Certified Shorthand
Reporter of the State of California, do hereby certify:
That I am a disinterested person herein; that the
foregoing California Air Resources Board, Scientific
Review Panel meeting was reported in shorthand by me,
James F. Peters, a Certified Shorthand Reporter of the
State of California;
That the said proceedings was taken before me, in
shorthand writing, and was thereafter transcribed, under
my direction, by computer-assisted transcription.
I further certify that I am not of counsel or
attorney for any of the parties to said meeting nor in any
way interested in the outcome of said meeting.
IN WITNESS WHEREOF, I have hereunto set my hand
this 3rd day of January, 2018.
JAMES F. PETERS, CSR
Certified Shorthand Reporter
License No. 10063
J&K COURT REPORTING, LLC 916.476.3171
128
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25